[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malaria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malaria":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,50,77,100,131,155,185,213,240,275,298,325,350,371,394,424,446,474,569,598,622,655,683,710,738],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100562733","phase-1-induced-blood-stage-malaria-in-healthy-malaria-naive-adults-to-assess-the-safety-and-infectivity-of-plasmodium-vivax-challenge-agent-and-evaluate-transmission-in-mosquito-feeding-assays-100562733",false,"NCT06607003","Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays","Phase 1 Study of Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays","* INCLUSION CRITERIA:\n\nAll of the following criteria must be fulfilled for a participant to undergo IBSM:\n\n1. Age \\>=18 and \\\u003C=54 years.\n2. RBCs positive for Duffy antigen\u002Fchemokine receptor.\n3. Malaria comprehension exam passed prior to study activities.\n4. Suitable accommodation and reliable access to the NIHCC for the duration of the study in the opinion of the investigator.\n5. Persons of childbearing potential must be willing to use reliable contraception from 28 days prior to challenge agent administration to the end of study.\n6. Signing of the informed consent form.\n7. Agreement to not live alone from challenge agent administration until the completion of antimalarial treatment.\n8. Agreement to long-term storage of study samples for future research.\n\nEXCLUSION CRITERIA:\n\nA participant will be excluded from participating in this trial if any 1 of the following criteria is fulfilled:\n\n1. Planned travel to a P. vivax-endemic area during the study period (see https:\u002F\u002Fwww.cdc.gov\u002Fmalaria\u002Ftravelers\u002Fcountry\\_table\u002Fa.html).\n2. History of travel to or residence in a P. vivax malaria-endemic region for more than 2 weeks during the past 2 years.\n3. Prior confirmed P. vivax malaria diagnosis or clinical history consistent with likely P. vivax infection. At the investigator's discretion, participants may be enrolled if the exposure was remote, e.g., \\> 5 years ago.\n4. Poor peripheral venous access, at the discretion of the investigator.\n5. For persons of childbearing potential:\n\n   1. Currently pregnant or breastfeeding, or planning on becoming pregnant or breastfeeding until the end of study.\n   2. Rh blood group negative.\n6. Being a current or former study team member or clinical trial staff with direct involvement of the trial, or being an employee supervised by a study team member.\n7. Unwillingness to defer blood donations for at least 3 years.\n8. Use of any of the following within the specified periods:\n\n   1. Investigational P. vivax vaccine within the last 2 years.\n   2. Malaria chemoprophylaxis within 3 months of Day 0.\n   3. Chronic systemic immunosuppressive medications (\\>14 days) within 6 months (e.g., cytotoxic medications, adrenocorticotrophic hormone, or oral\u002Fparental corticosteroids equivalent to \\>0.5 mg\u002Fkg\u002Fday of prednisone). Corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are allowed.\n   4. Prior receipt of packed red cells or other blood products or immunoglobulins within the previous 6 months.\n   5. Systemic antibiotics or medications with potential antimalarial effects less than 28 days before Day 0 (e.g., clindamycin, chloroquine, benzodiazepines, tetracycline, azithromycin, or doxycycline).\n   6. Investigational product or vaccine less than 28 days before Day 0.\n   7. Receipt of any vaccination less than 28 days before Day 0.\n   8. Current or planned use of medications known to significantly prolong the QT interval or otherwise interfere with study agents.\n   9. Smoking more than 5 cigarettes or equivalent per day and unable to stop smoking for the duration of admission. Participants may smoke up to 5 cigarettes or equivalent per day for the rest of the study (by attestation).\n   10. History of alcohol use disorder (exceptions may be made at the investigator's discretion if they have completed treatment or are otherwise currently abstinent) or refusal to agree to refrain from drinking from the day of the challenge agent inoculation until completion of their antimalarial course.\n9. Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history including:\n\n   1. Immunodeficiency including asplenia or functional asplenia or significant autoimmune disease.\n   2. Retinal disease, visual field changes, psoriasis, porphyria, or known allergy to chloroquine or artemether\u002Flumefantrine.\n   3. Cardiac disease including \\>10% cardiovascular risk as determined by the non-laboratory method or an abnormal EKG demonstrating a corrected QT interval by Fridericia's formula of \\>450 msec or other concerning arrhythmia.\n   4. Any other medical condition that may have significant implications for current health status and participation in the study, in the opinion of the investigator.\n10. History of a severe reaction to arthropod bites, or history of anaphylaxis or severe unexpected allergy to any substance.\n11. Screening blood test or urinalysis laboratory parameters outside of local lab normal range (including infectious serologies). Participants may be included at the investigator's discretion for \"not clinically significant\" values outside of normal range.\n12. Any other finding that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study.\n\nParticipants who are determined ineligible to participate for any of the reasons above may be rescreened for eligibility at a later time when the disqualifying condition may be resolved.",true,"ALL","18 Years","54 Years",{"count":22,"type":23},300,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","Background:\n\nMalaria is a disease caused by parasites transmitted to people by mosquitoes. Around the world, there were 241 million cases and 627,000 deaths from malaria in 2020. Researchers are working to develop vaccines and treatments for this disease.\n\nObjective:\n\nTo learn how malaria develops in people; how the body's immune system reacts to malaria; and how malaria spreads from people to mosquitoes.\n\nEligibility:\n\nHealthy people in the Washington DC area, aged 18 to 54 years. They cannot live alone during parts of the study.\n\nDesign:\n\nParticipants will be infected with a parasite that causes malaria. The parasite will be in donated blood; it will be given through an IV.\n\nParticipants will likely develop symptoms within a week after the injection. Researchers will call daily to check on their health. After about 6 days, participants will come to the NIH clinic each day for blood tests.\n\nParticipants will check in to the NIH clinic around 10 days after the injection. They will stay in the clinic 3 to 6 days. They will have multiple blood tests every day.\n\nParticipants will be bitten by mosquitoes up to 4 times. Cups containing mosquitoes will be held against their skin for 15 minutes.\n\nParticipants will begin taking chloroquine close to the end of their clinic stay. Chloroquine is a pill taken by mouth once or twice a day for 3 days. It is FDA-approved to treat malaria.\n\nParticipants will have follow-up visits 1 and 3 weeks after discharge.",[29],"Malaria",[31,32,33,34,35,36],"IBSM","Challenge","inoculation","Parasitemia","Mosquito Feeding Assay","Malaria Transmission","RECRUITING","2026-06-27",{"date":40,"type":41},"2026-06-30","ACTUAL",{"date":43,"type":41},"2024-11-26",{"date":45,"type":23},"2027-11-26",{"name":47,"class":48},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":4,"leadSponsor":75,"locationsCount":76},"100145734","host-and-parasite-factors-that-influence-susceptibility-to-malaria-infection-and-disease-during-pregnancy-and-early-childhood-in-ouelessebougou-and-bamako-mali-100145734","NCT01168271","Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali","* INCLUSION CRITERIA:\n\nA study participant must satisfy the following criteria to be or have been enrolled in this study:\n\n1. Pregnant women aged 15-45 years and their newborn infants who are residents of the district of Ouelessebougou for at least one year at the time of enrollment (cohort completed clinical follow up; sample and data analysis ongoing); OR\n2. Children who previously participated in the 1st cohort of \"pregnant women and their newborn infants\", OR\n3. Children aged 3 years or less, who are residents of the district of Ouelessebougou for at least one year at the time of enrollment (cohort completed clinical follow up; sample and data analysis ongoing), OR\n4. Febrile hospitalized children (aged 0-10 years), including those with positive and negative blood smears for P. falciparum in Ouelessebougou or the pediatric service of Gabriel Toure Hospital in Bamako. Febrile non-hospitalized children (aged 0-10 years) with non-severe malaria will be recruited at outpatient clinics in Ouelessebougou district health hospital and nearby facilities, with no chronic or serious illness.\n5. Pregnant women aged 15-25 in Ouelessebougou district health centers or maternity unit of Gabriel Toure Hospital in Bamako and for a case-control study of pregnancy malaria and preeclampsia. Cases include women with signs\u002Fsymptoms of preeclampsia. Control pregnant women without signs\u002Fsymptoms of preeclampsia will be recruited sequentially after identification of individual cases, matched for parity, age (+\u002F-2 years) and pregnancy trimester.(cohort completed clinical follow up; sample and data analysis ongoing)\n6. The study participant or parent\u002Fguardian understands the study and gives informed consent for participation of themselves and\u002For their child, and agrees to have samples stored.\n\nEXCLUSION CRITERIA:\n\nA participant will be excluded from the study if any one or more of the following criteria are met:\n\n1. Chronic, debilitating illness, other than malaria, determined by history and physical examination of mother or study participant.\n2. Conditions that in the judgment of the investigator could increase the risk to the volunteer.\n3. History of previous participation in a malaria vaccine trial.","1 Day","45 Years",{"count":59,"type":23},15000,"OBSERVATIONAL","Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors associated with infection and disease is badly needed; and will accelerate the development of highly protective vaccines for both mothers and children. Pregnancy malaria is associated with low birth weight, maternal anemia, and gestational hypertension, and both inflammation and the fetal response to infection may contribute to these poor outcomes. Childhood malaria is a major cause of mortality, and we have found that its risk is related to in utero exposure to pregnancy malaria, as well as other host factors like iron status and constitutive cytokine levels. Pregnancy malaria is caused by a distinct parasite binding phenotype, and as our primary hypothesis in this study we speculate that severe childhood malaria parasites may also have distinct features. A longitudinal cohort study will be conducted in Ouelessebougou, Mali, an area of intense seasonal transmission. Up to 2000 pregnant women and their infants and 2000 children aged 0-3 years will be enrolled and followed to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples being obtained. In addition, up to 3000 febrile hospitalized and non-hospitalized children up to 10 years ofd age will be enrolled at the Ouelessebougou district health centers or the Gabriel Toure Pediatric Hospital in Bamako, Mali, with acute and convalescent samples being obtained and 500 pregnant women enrolled at the health centers and hospital in Ouelessebougou district or the Gabriel Toure Hospital in Bamako for a case-control study on pregnancy malaria and preeclampsia. Up to 1000 children originally enrolled at birth and completed the \"pregnant women and their newborns study\" will be re-enrolled and followed for up to 10 years as they age from later childhood through adolescence to early adulthood. Clinical, parasitologic and host response (including immunologic) endpoints will be analyzed using appropriate statistical methods, including possible confounders, to determine factors associated with infection and disease in pregnant women and young children.",[29],[64,65,66,67,68,69],"Observational","Newborns","Hospitalized","Febrile","Resistance","Natural History","2026-06-19",{"date":72,"type":41},"2026-06-23",{"date":74,"type":41},"2010-08-30",{"name":47,"class":48},2,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":49},"100357727","collection-of-human-biospecimens-for-basic-and-clinical-research-into-globin-variants-100357727","NCT03937817","Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants","* PARTICIPANT INCLUSION CRITERIA:\n\n  1. Aged 18-70 years.\n  2. Able to provide informed consent.\n  3. Willing to allow biological samples to be stored for future research.\n  4. Willing to provide one or more of the following tissues: saliva, urine, blood, blood waste products, adipose tissue, bronchial brushing, and\u002For BAL samples.\n  5. Willing to allow genetic testing on collected biological samples.\n\n     PARTICIPANT EXCLUSION CRITERIA:\n* Exclusion Criteria for All Participants\n\nThe following exclusion criteria apply to all participants who will provide any of the following samples in-person at the NIH CC: saliva, urine, blood, blood waste products, adipose tissue, bronchial brushing, and\u002For BAL samples:\n\n1. Pregnancy.\n2. Positive testing for hepatitis B virus, hepatitis C virus, or HIV (as determined by serum screening tests or relevant viral quantitative studies.)\n3. Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.\n4. Any condition that, in the opinion of the PI, contraindicates participation in this study.\n\n   * Additional Exclusion Criteria for Individuals Giving Blood for Research\n\n1\\. Hemoglobin \\\u003C 10 g\u002FdL for healthy female volunteers, \\\u003C 12 g\u002FdL for healthy male volunteers, or \\\u003C 6 g\u002FdL for participants with sickle cell disease or other chronic anemias.\n\n-Additional Exclusion Criteria for Adipose Tissue Biopsy\n\nIndividuals meeting any of the following criteria will be excluded from undergoing adipose tissue biopsy. If the participant no longer meets any of these criteria at a later time, then they will be allowed to undergo this procedure.\n\n1. Currently taking anticoagulation medication.\n2. Platelets \\\u003C 100,000\u002FmicroL.\n3. History of keloid formation (or irregular fibrous tissue formed at the site of a scar or injury).\n4. History of adverse reactions to lidocaine or other local anesthetics.\n5. Any condition that, in the opinion of the PI, contraindicates this procedure.\n\nUse of aspirin (or acetylsalicylic acid) and nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted.\n\n-Additional Exclusion Criteria for Bronchoscopy\n\nIndividuals meeting any of the following criteria will be excluded from undergoing bronchoscopy. If the participant no longer meets any of these criteria at a later time, then they will be allowed to undergo this procedure.\n\n1. Prothrombin time (PT) \\> 1 second above the upper limit of normal (ULN) or international normalized ratio \\> 1.3.\n2. Partial thromboplastin time (PTT) \\> 1 second above ULN.\n3. Platelets \\\u003C 150,000\u002FmicroL.\n4. Currently taking anticoagulation medication.\n5. Use of aspirin within 2 weeks of the bronchoscopy or NSAIDs within 2 days of the bronchoscopy.\n6. Diagnosis of a pulmonary disorder (eg, asthma, chronic bronchitis, cystic fibrosis, or bronchiectasis).\n7. Respiratory tract infection within the last 4 weeks.\n8. History of adverse reactions to systemic and\u002For local anesthetics that will be used for this procedure.\n9. History of cigarette smoking within the past 3 months.\n10. History of chronic opioid use.\n11. History of drug or alcohol abuse.\n12. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \\\u003C 40% of predicted or pre-bronchodilator FEV1 \\\u003C 35% of predicted.\n13. Active bronchospasm on physical examination.\n14. History of lidocaine allergy.\n15. Any condition that, in the opinion of the PI, contraindicates this procedure.\n\nCo-enrollment guidelines: Participants may be co-enrolled in other studies. However, the PI must be notified of co-enrollment.","70 Years",{"count":22,"type":23},"Background:\n\nBlood disorders like sickle cell disease and malaria affect many people around the world. Researchers want to learn more about blood disorders. To do this, they need to collect biological samples from people with blood disorders. They also need to collect samples from healthy people.\n\nObjective:\n\nTo collect samples to use for research on blood disorders.\n\nEligibility:\n\nPeople ages 18-70 who have blood disorders. Healthy volunteers without blood disorders are also needed.\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood and urine tests.\n\nParticipants will give one or more samples. They will give them over 5 years. They can choose not to give any of the samples:\n\nSaliva: Participants will spit into a tube. They may also have the inside of their mouth swabbed.\n\nUrine: Participants will urinate into a cup.\n\nBlood and blood waste products: Blood will be taken through a needle in the participant s arm.\n\nFat samples: An area on the participant s belly or buttock will be numbed. A small cut will be made into the skin and a small piece of fat removed.\n\nMucus and cells from the lungs: The participant will be sedated. A flexible tube will be inserted through the nose or mouth into the lung airways. These participants will also have a physical exam, chest x-ray, and heart tests after the procedure.\n\n...",[87,88,29,89],"Alpha and Beta Thalassemia","Sickle Cell Disease","Human Physiology",[91,29,88,87,69],"Assay Development","2026-06-17",{"date":94,"type":41},"2026-06-18",{"date":96,"type":41},"2019-09-25",{"date":98,"type":23},"2029-03-31",{"name":47,"class":48},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":24,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":49},"100492338","phase-3-focal-mass-drug-administration-for-vivax-malaria-elimination-100492338","NCT05690841","FocaL Mass Drug Administration for Vivax Malaria Elimination","FocaL Mass Drug Administration for Vivax Malaria Elimination (FLAME): a Pragmatic Cluster Randomized Controlled Trial in Peru","FLAME","Inclusion Criteria:\n\n1. Cluster eligibility\n\n   * Within 8 hours transport of Iquitos\n   * Incidence \\\u003C250\u002F1000 and \\>2 cases year prior to trial\n   * Population size (\\\u003C650)\n2. Chloroquine (CQ) eligibility\n\n   * Resides in neighboring household but within 200 m of Pv index case in the past 2 years\n   * Age ≥6 months old\n   * Present for intervention\n   * Adult ≥18 years old that provides informed consent\n   * A child ≥8 years and \\\u003C18 years old that provides informed assent and has informed consent from their parents\n   * A child ≥6 months old and \\\u003C8 years old that has informed consent from their parents\n3. Tafenoquine (TQ) eligibility\n\n   * Eligible to receive CQ\n   * Age ≥16 years old\n   * Adult ≥18 years old that provides informed consent\n   * A child ≥16 years and \\\u003C18 years old that provides informed assent and has informed consent from their parents\n4. Primaquine eligibility\n\n   * Eligible to receive CQ and ineligible to receive TQ\n   * Age ≥6 months old\n   * Adult ≥18 years old that provides informed consent\n   * A child ≥8 years and \\\u003C18 years old that provides informed assent and has informed consent from their parents\n   * A child ≥6 months old and \\\u003C8 years old that has informed consent from their parents\n5. Baseline evaluation and informed consent\n\n   -Villagers will be eligible to participate in surveys if they slept in a household in cluster randomized to control or focal mass drug administration (fMDA) for at least one night in the past four weeks\n6. Eligibility for fMDA\n\n   * High-risk villagers are defined as individuals residing in households that are within 200 meters of a Plasmodium vivax index case households from the prior 2 years (including individuals in the index case household) will be eligible to receive fMDA that cycle\n   * Villagers that were eligible but missed in the 1st round in a cycle, or become eligible in the next two months, will not be eligible to receive fMDA in the 2nd round in a cycle.\n\nExclusion Criteria:\n\n1. Chloroquine eligibility\n\n   * History of retinal or visual field changes\n   * Known hypersensitivity or adverse reaction to CQ\n   * Currently taking CQ or have taken CQ in the past four weeks\n   * Ineligible for TQ or PQ (see criteria below)\n   * Hemoglobin \\\u003C9 g\u002FdL\n2. Tafenoquine eligibility\n\n   * G6PD deficiency or intermediate status (defined as activity ≤6.0 UI\u002FgHb per SD biosensor)\n   * G6PD status unknown or refusal of G6PD status test\n   * Acute or severe malaria\n   * Pregnancy (known or identified by pregnancy test)\n   * Refusal of pregnancy test if new amenorrhea in the past 4 weeks\n   * Woman breastfeeding a child that is G6PD deficient or with unknown G6PD status\n   * Known hypersensitivity or adverse reaction to TQ or PQ\n   * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks\n   * Hemoglobin \\\u003C 9 g\u002FdL\n3. Primaquine eligibility\n\n   * G6PD deficiency (defined as activity ≤4.0 UI\u002FgHb per SD biosensor)\n   * G6PD status unknown or refusal of G6PD status test\n   * Acute or severe malaria\n   * Pregnancy (known or identified by pregnancy test)\n   * Refusal of pregnancy test if new amenorrhea in the past 4 weeks\n   * Breastfeeding child with documented or unknown G6PD deficiency status\n   * Woman breastfeeding a child with documented or unknown G6PD deficiency status\n   * Known hypersensitivity or adverse reaction to TQ or PQ\n   * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks\n   * Hemoglobin \\\u003C 9 g\u002FdL",{"count":109,"type":23},7530,[111],"PHASE3","FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru. Standard interventions, including symptomatic and asymptomatic screening for malaria infections, provision of insecticide-treated bednets, and environmental transmission monitoring, will be compared to clusters of villages randomized to receive anti-malarial drugs.",[114,29],"Plasmodium Vivax Malaria",[116,117,118,119,120],"Antimalarial drugs","Primaquine","Chloroquine","Tafenoquine","Parasitic disease","2026-06-05",{"date":123,"type":41},"2026-06-09",{"date":125,"type":41},"2024-10-14",{"date":127,"type":23},"2027-05-01",{"name":129,"class":130},"University of California, San Francisco","OTHER",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":49},"100258132","screening-of-healthy-volunteers-for-investigational-antimalarial-drugs-malaria-vaccines-and-controlled-human-malaria-challenge-100258132","NCT02639299","Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge","* INCLUSION CRITERIA:\n\nAll of the following criteria must be fulfilled for a subject to participate in this trial:\n\n1. Age \\>= 18 and \\\u003C= 50 years.\n2. In good general health and without clinically significant medical history\n3. Reliable access to the clinical trial center and available in the area for more than 1 year\n4. Females of childbearing potential must be willing to undergo periodic pregnancy testing and use reliable contraception per protocol when enrolled into LMIV clinical trials (protocol-specific requirements)\n\nEXCLUSION CRITERIA:\n\nA subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:\n\n1. Pregnant, breastfeeding, or planned pregnancy in the upcoming year.\n2. Hemoglobin, white blood cell (WBC), platelets, alanine transaminase (ALT), and creatinine (Cr) outside of local lab normal range (subjects may be included at the investigator's discretion for \"not clinically significant\" values outside of normal range).\n3. Anticipated use during the study period, or use within the following periods prior to enrollment:\n\n   1. Investigational malaria vaccine within the last five years\n   2. Chronic systemic immunosuppressive medications (e.g., cytotoxic medications, oral\u002Fparental corticosteroids \\> 0.5 mg\u002Fkg\u002Fday prednisone or equivalent). Corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis is allowed.\n   3. Recurrent receipt of blood products or immunoglobulins\n4. History of:\n\n   1. Sickle cell disease\n   2. Splenectomy or functional asplenia\n   3. Systemic anaphylaxis\n   4. Uncontrolled psoriasis or porphyria\n5. Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status and participation in the study in the opinion of the Investigator. A clinically significant condition or process includes but is not limited to:\n\n   1. A process that would affect the immune response, or requires medication that affects the immune response.\n   2. Any contraindication to repeated phlebotomy.\n6. History of or known active cardiac disease including:\n\n   1. prior myocardial infarction (heart attack)\n   2. angina pectoris\n   3. congestive heart failure\n   4. valvular heart disease\n   5. cardiomyopathy\n   6. pericarditis\n   7. stroke or transient ischemic attack\n   8. exertional chest pain or shortness of breath\n   9. other heart conditions under the care of a doctor\n7. Infection with HIV, hepatitis B, and\u002For hepatitis C\n8. Psychiatric condition that precludes compliance with the protocol including but not limited to:\n\n   1. Psychosis within the past 3 years\n   2. Ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years\n9. Suspected or known current alcohol or drug abuse as defined by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition at the discretion of the PI\n10. Any other finding that, in the judgment of the Investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a subject's ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study","50 Years",{"count":139,"type":23},1500,"Background:\n\nMalaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can also affect travelers who have never been exposed to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine, antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited under a general screening study in order to see if are qualified to join a future malaria study.\n\nObjective:\n\nTo screen healthy volunteers to see if they are eligible to join investigational malaria studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines, or prevention regimens. They may also involve controlled human malaria infection trials.\n\nEligibility:\n\nHealthy people ages 18 50\n\nDesign:\n\nParticipants will first be prescreened by phone.\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nParticipants may go more than 1 year without joining a clinical trial. If this happens, they may be re-contacted to see if they still want to be part of this screening protocol. Those who still want to participate and have had relevant medical changes will be rescreened.",[29],[143,144,145,146,147],"Subjects","Venipuncture","Research","Evaluate","Recruit",{"date":149,"type":41},"2026-06-08",{"date":151,"type":41},"2016-12-08",{"date":153,"type":23},"2030-09-30",{"name":47,"class":48},{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":24,"phases":166,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":49},"100626050","phase-2-this-is-a-clinical-study-to-assess-whether-the-combination-of-sj733-and-tafenoquine-will-be-a-safe-and-rapidly-acting-anti-malarial-for-the-radical-cure-of-p-vivax-malaria-100626050","NCT07430592","This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria","A Phase 2B Trial of the Combination of SJ733 and Tafenoquine for Radical Cure of P. Vivax Malaria in Comparison to Chloroquine-Tafenoquine","SJ733-2002","Inclusion Criteria:\n\n* Body weight between 45 kg and 90 kg inclusive.\n* Presence of mono-infection of P. vivax confirmed by: Fever, as defined by axillary temperature ≥ 37.5°C or oral\u002Frectal\u002Ftympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and, Microscopically confirmed parasite infection: 1,000 to 40,000 asexual parasite count\u002FµL blood\n* Written informed consent provided by participant, in accordance with local practice. If the participant is unable to write, witnessed consent is permitted according to local ethical considerations.\n* Ability to swallow oral medication.\n* Ability and willingness to participate and to comply with the study requirements.\n* Agreement to hospitalization for at least 72 hours and\u002For until malarial parasites are not detected by microscopy on 2 consecutive occasions.\n* Agreement to come back to the hospital on Days 4, 7, 14, 21, 28, 35, 42, 60, 120, and 180.\n* A female participant meets eligibility in this study if she is non-pregnant, non-lactating and if she is of: non-childbearing potential defined as: post-menopausal (12 months of spontaneous amenorrhea or \\\u003C6 months of spontaneous amenorrhea with serum FSH \\>40 mIU\u002FmL), pre-menopausal and has had a hysterectomy, a bilateral oophorectomy (removal of the ovaries), or a bilateral tubal ligation with medical report verification, negative pregnancy test or, child-bearing potential, with a negative pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 75 days after stopping study treatment:\n\n  i. Use of oral, implantable, or injectable hormonal contraceptive, either combined or progestogen alone, used in conjunction with barrier method (condom or diaphragm).\n\nii. Use of an intrauterine device with a documented failure rate of \\\u003C1% per year.\n\niii. Double barrier method consisting of condom and diaphragm. iv. Male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for that female.\n\nv. Complete abstinence from intercourse throughout the study and for a period of 75 days after stopping study treatment.\n\n* A male participant meets eligibility in this study if he meets one of the following conditions:\n\n  1. is sterile prior to participating in the study.\n  2. agrees to the use of a contraceptive method (such as a condom) through the administration of study treatment and for a period of 75 days after stopping study treatment.\n  3. agrees to complete abstinence from intercourse throughout the study and for a period of 75 days after stopping study treatment.\n\nExclusion Criteria:\n\n* Signs and symptoms of severe\u002Fcomplicated malaria according to the World Health Organization Criteria 2010.\n* Mixed Plasmodium infection or Plasmodium mono-infection with any Plasmodium species other than P. vivax.\n* Severe vomiting, defined as more than three times in the 24 hours prior to the planned first dose of drug, or severe diarrhea defined as 3 or more watery stools per day.\n* Severe malnutrition (defined as the weight-for-height being below -3 standard deviation or less than 70% of median of the NCHS\u002FWHO normalized reference values).\n* The presence of a significant medical or psychiatric condition, or any other serious or chronic clinical condition requiring hospitalization, or any other condition that in the opinion of the investigator precludes participation in the study.\n* Female participants must not be lactating or pregnant as demonstrated by a negative serum point-of-care pregnancy test pre-dose (the result of the pre-dose assessment must be confirmed negative prior to dosing).\n* Employment under the direct supervision of the investigators or study staff.\n* Clinically significant alterations to hematologic or clinical chemistry parameters that in the opinion of the investigator precludes participation in the study, including:\n\n  1. AST\u002FALT \\> 3 x upper limit of normal range (ULN) and total bilirubin is normal.\n  2. AST\u002FALT \\> 2 x ULN and total bilirubin is \\>1 and \\\u003C2 x ULN and conjugated bilirubin is \\> 2x ULN.\n  3. Serum creatinine levels \\> 2 x ULN\n  4. Uncorrected electrolyte abnormalities \\[\\> 3x ULN or LLN\\]\n\n  i. Potassium\\[hypokalemia\\] ii. Magnesium \\[hypomagnesemia\\] e. Hb level \\\u003C 9 g\u002FdL f. Platelet level \\\u003C 50,000\u002Fmm3\n* Clinically significant alterations to cardiac function\n\n  1. Unstable angina with elevated serum cardiac biomarkers, ECG changes, etc.; those with NSTE-ACS, NSTEMI, STEMI, or definite acute coronary syndrome.\n  2. Congestive heart failure\n  3. Recent history of Myocardial Infarction\n  4. QT prolongation (\\>450 milliseconds (ms) in men and 460 ms in women)\n* Participation in a clinical study of another small investigational molecule within 30 days or investigational biologic within 90 days prior to study enrollment or planning to begin such participation during the study.\n* Received any antimalarial treatment (alone or in combination) in the past containing:\n\n  1. Tafenoquine within the previous 4 months\n  2. Piperaquine, mefloquine, naphthoquine or sulphadoxine \u002F pyrimethamine within the previous 5 months\n  3. Amodiaquine or chloroquine within the previous 5 months\n  4. Any artemisinin (artesunate, artemether, arteether or dihydroartemisinin), quinine, halofantrine, lumefantrine and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 3 months.\n* Known history of hypersensitivity, allergic, or adverse reactions to SJ733, tafenoquine or other 8-aminoquinolines, or chloroquine or other 4-aminoquinolines.\n* Current use of prohibited concomitant medications (Appendix III)\n* Known neuropsychiatric disorders.\n* G6PD deficiency \\\u003C70% normal enzyme activity.\n* Prohibited use of metoclopramide, antibiotics including fluoroquinolones\n* Positive HIV and\u002For Hepatitis B, C test results","76 Years",{"count":165,"type":23},104,[167],"PHASE2","The goal of this Phase 2b study is to examine the safety and efficacy of the combination of SJ733, an investigational agent, and tafenoquine for the radical cure of uncomplicated P. vivax malaria monoinfection in adult participants and determine the contributions of SJ733 to the effect. SJ733 will be administered in a 1-, 2-, or 3-day treatment schedule in combination with a single dose of tafenoquine.",[29,170,171],"Malaria Vivax","Radical Cure",[173,174],"SJ733","SJ733 with Tafenoquine","NOT_YET_RECRUITING","2026-05-22",{"date":178,"type":41},"2026-05-28",{"date":180,"type":23},"2026-07-01",{"date":182,"type":23},"2028-11-20",{"name":184,"class":130},"R. Kiplin Guy",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":17,"sex":192,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":49},"100245280","laboratory-evaluation-of-pregnancy-malaria-vaccine-candidatesin-vitro-testing-of-pregnancy-malaria-vaccine-candidates-100245280","NCT02471378","Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates\u002FIn-vitro Testing of Pregnancy Malaria Vaccine Candidates","In-Vitro Testing of Pregnancy Malaria Vaccine Candidates","* INCLUSION CRITERIA:\n\nA study participant must satisfy the following criteria to be enrolled in this study:\n\n* Pregnant women aged 15-25 years\n* Able to provide consent for self\n* Malaria positive by rapid diagnostic test (RDT)\n\nEXCLUSION CRITERIA:\n\n* Severe anemia defined as HGB\\\u003C7 gr\u002FdL, that may be worsened by 10 mL phlebotomy\n* Conditions that in the judgment of the investigator could increase the risk to the volunteer\n* Prior enrollment to the study during the same pregnancy","FEMALE","15 Years","25 Years",{"count":196,"type":23},7476,"Background:\n\n\\- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy.\n\nObjectives:\n\n\\- To create a vaccine that will prevent malaria infection during pregnancy. To assess possible vaccines using in-vitro tests with parasites taken from pregnant women.\n\nEligibility:\n\n\\- Pregnant women ages 15-25\n\nDesign:\n\n* The study site is an area in Mali, West Africa.\n* Participants:\n* Will have blood drawn.\n* Will give consent for the blood sample to be used for future research.\n* May have a physical exam.\n* Participants who have malaria or anemia will get treatment.",[29],[200,201,202,203,204,69],"Assays","Women","Infected","Antibodies","Plasmodium Falciparum","2026-05-15",{"date":207,"type":41},"2026-05-18",{"date":209,"type":41},"2015-07-28",{"date":211,"type":23},"2028-06-30",{"name":47,"class":48},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":24,"phases":224,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":49},"100611895","phase-4-intermittent-preventive-treatment-of-malaria-in-school-age-children-to-decrease-community-transmission-100611895","NCT07246525","Intermittent Preventive Treatment of Malaria in School-age Children to Decrease Community Transmission","Cluster Randomized Trial of Intermittent Preventive Treatment of Malaria in School-age Children to Improve the Health of Students and Decrease Community Transmission","CRITICal","Inclusion Criteria:\n\n* Child currently attending the participating school.\n* Agreement of parent\u002Fguardian to provide informed consent.\n* Agreement of children aged 8-17 years to provide assent.\n\nExclusion Criteria:\n\n* Missing school on three consecutive days of the school survey.","17 Years",{"count":223,"type":23},4800,[225],"PHASE4","The CRITICal study aims to estimate the effectiveness of intermittent preventive treatment in school children (IPTsc) with dihydroartemisinin-piperaquine (DP) for reducing community level malaria burden. Given that school-aged children are the primary drivers of transmission, the study hypothesis is that IPTsc will reduce this infectious reservoir and thus the burden of malaria in persons of all ages in surrounding communities.",[29],[229,230,231],"intermittent preventive treatment","school children","dihydroartemisinin-piperaquine","2026-05-05",{"date":234,"type":41},"2026-05-07",{"date":236,"type":23},"2026-08-01",{"date":238,"type":23},"2029-08-31",{"name":129,"class":130},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":17,"sex":18,"minAge":247,"maxAge":137,"enrollmentInfo":248,"targetDuration":4,"studyType":24,"phases":250,"briefSummary":251,"conditions":252,"keywords":259,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":49},"100635079","phase-1-safety-and-pk-of-mmv371-lai-in-healthy-adults-and-adolescents-in-rwanda-100635079","NCT07548021","Safety and PK of MMV371 LAI in Healthy Adults and Adolescents in Rwanda","A Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 Long-Acting Injection in Healthy Adults and Adolescents in Rwanda","Inclusion Criteria:\n\n1. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents, written assent and parental\u002Flegal authorized representative (LAR) consent must be obtained, in accordance with local regulations.\n2. Able to provide proof of identity to the satisfaction of the Investigator or delegate completing the enrolment process\n3. Able and willing to communicate effectively and comply with all study procedures for the duration of the study (including IM injections, safety assessments, blood sampling, malaria monitoring, follow-up visits)\n4. Living within local jurisdiction of trial site(s) and available for the duration of the trial Demographics and Contraception\n5. Male or female participants aged 12 to 50 years inclusive at the time of signing informed consent\u002Fassent.\n6. WOCBP must be non-pregnant and non-lactating, confirmed by a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test at admission, prior to IMP administration. WOCBP must agree to use, at minimum, acceptable contraception methods, as defined by the Clinical Trials Coordination Group (CTCG) guidance, from 21 days prior to study Day 1 through the End-of Study visit (Week 24) (Clinical Trials Coordination Group (CTCG), 2024).\n7. Post-menopausal participants must have menopause confirmed at screening, defined as a follicle-stimulating hormone (FSH) level ≥ 25.8 mIU\u002FmL Baseline Characteristics\n8. Healthy volunteers, as determined by:\n\n   physical examination Vital signs 12 lead ECG absence of malaria symptoms at baseline (note: a positive blood smear without malaria symptoms at baseline is not exclusionary) Hematology, biochemistry or urinalysis results at screening or at the admission visit (Day -1) that are within the standard clinically acceptable laboratory ranges defined for this study (See section 10.7 Appendix 7)\n9. For adults (18-50 years): Body Weight ≥45 kg at screening\n10. For adolescents (12-17 years): body weight ≥35 kg at screening Participant-reported outcomes (PROs)\n11. Able to understand and complete participant-reported outcome assessments (e.g., injection-site reaction diary and injection acceptability assessments), either independently or with assistance, in a language and format approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* Medical Conditions\n\n  1. Positive malaria blood smear microscopy at the Admission visit (Day -1).\n  2. Acute febrile illness within 96 hours prior to enrolment or within 96h prior to Day 1.\n  3. Serious adverse reaction or clinically significant hypersensitivity to drugs or formulation excipients used in the study: artemether-lumefantrine (Coartem® or generic formulations) and atovaquone (Wellvone®\u002FMepron® and\u002For Malarone® or their generics).\n  4. Any history of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis prior to enrolment that, in the opinion of the Investigator, has a reasonable risk of recurrence during the trial.\n  5. Any current uncontrolled medical or psychiatric condition, or substance abuse problems that, in the opinion of the Investigator, would make it unlikely for the participant to comply with the protocol, may interfere with study assessments, or could jeopardize the safety of the participant.\n  6. Evidence of clinically significant neurologic, cardiac, gastro-intestinal, dermatologic, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, haematological, oncologic, or renal disease, as determined by medical history, physical examination, and\u002For laboratory evaluations, including urinalysis.\n  7. History of a bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or a history of significant bruising with blood draws.\n  8. Known or documented sickle cell disease by history. Note: known sickle cell trait is not exclusionary.\n  9. Presence of sinus node dysfunction; clinically significant PR interval prolongation (\\>220 msec); intermittent second- or third-degree atrioventricular block; complete bundle branch block; sustained cardiac arrhythmias including, but not limited to, atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia except isolated extrasystoles; abnormal T wave morphology that may interfere with QT\u002FQTc assessment; or QTcF \\>450 msec (adults and adolescents).\n\n     Physical Examination\n  10. Participants who do not have adequate venous access for multiple venipunctures or cannulation, as assessed by the Investigator or delegate at screening.\n  11. Participants with tattoos, scars or other clinically significant dermatological lesions or conditions overlying the deltoid, gluteal, or vastus lateralis region that, in the opinion of the Investigator, may interfere with injection site assessments.\n\n      Diagnostic Assessments\n  12. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab). or human immunodeficiency virus (HIV) 1 and 2 antibody results.\n\n      Prior Study Participation\n  13. Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or within fewer than 5 elimination half-lives prior to Day 1 (whichever is longer). Note: Past, current, or planned participation in non-interventional (observational) studies is not exclusionary.\n  14. Participants who are currently enrolled in another interventional clinical trial within 90 days prior to Day 1, or who intend to participate in another interventional clinical trial during their participation in this study.\n  15. Donation of blood or plasma, or loss of more than 400 mL of blood, within 90 days prior to Day 1.\n\n      Prior and Concomitant Medication or Vaccine\n  16. Use of antimalarial chemoprevention or treatment, and\u002For antibiotics with known antimalarial activity (see Section 10.6 Appendix 6), within 6 weeks or fewer than 5 elimination half-lives prior to Screening (whichever is longer).\n  17. Current or recent (within 30 days prior to Day 1) use of rifampin\u002Frifampicin, rifabutin, tetracycline, or indinavir due to potential drug-drug interaction risk with atovaquone.\n  18. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \\>10 mg\u002Fday) or other immunosuppressive drugs within 30 days prior to Day 1.\n  19. Receipt of a live attenuated vaccine within 4 weeks or an inactivated vaccine within 2 weeks prior to Day 1.\n  20. Receipt or planned receipt during the study of any doses of a malaria vaccine (investigational or registered, such as RTS, S\u002FAS01 or R21\u002FMatrix-M) or monoclonal antibodies (mAb) directed against Plasmodium falciparum.\n  21. Receipt of immunoglobulins and\u002For blood products within the past 6 months. Lifestyle Characteristics\n  22. History or medical, occupational, or family problems related to alcohol or illicit drug use within the past 12 months that, in the opinion of the Investigator, may interfere with study participation, compliance, or participant safety.\n\n      Other Exclusion Criteria\n  23. Participants who are, or are immediate family members of, study site staff or Sponsor employees involved in the conduct of the study.\n  24. Any other condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study or could compromise participant safety or data integrity.","12 Years",{"count":249,"type":23},80,[26],"This Phase 1b study will assess the safety, tolerability and pharmacokinetics (PK, this measures the levels of study drug in the body) of a single injection of MMV371 in healthy adult and adolescent participants in Rwanda. MMV371 has been designed as a long acting injection (LAI). Protective efficacy (PE) will be assessed as an exploratory endpoint. Protective efficacy measures if participants are protected from becoming ill with malaria whilst the MMV371 is still present in their body. The study will enroll approximately 80 healthy male and female participants, aged 12 to 50 years. Before starting the study participants will be given a standard approved course of artemether lumifantrine (AL) to clear any malaria infection they have. Once the AL course has been completed the study drug will be given by injection in the muscle of the upper arm, the side of the thigh, or the hip. Three out of four participants will receive MMV371 and 1 in four participants will receive placebo. Placebo is a dummy medicine. All participants have an equal chance of being assigned to receive the injection in the upper arm, outer thigh or hip. Neither the participants nor the researchers treating the participants will know who received MMV371 or placebo until after the study is completed.\n\nKey study features include:\n\n* Study duration for each participant: up to 7 months\n* MMV371 or placebo given: a single intramuscular (IM) injection\n* Visit schedule: Participants will remain in-clinic on Days -1-2 (2 overnight stays), followed by 15 follow-up visits: Day 4, then weekly for 1 month, and subsequently every 2 weeks until the End-of-Study (EoS) visit at Week 24.\n\nThese frequent visits are necessary to monitor safety, the levels of MMV371 in the body, and to perform malaria detection testing until EoS (Week 24).",[253,254,255,256,257,29,258],"Malaria (Plasmodium Falciparum)","Malaria Falciparum","Malaria Infection","Malaria Prophylaxis","Malaria Prevention","Malaria Parasitaemia",[260,261,262,263,264,265],"malaria prevention","malaria prophylaxis","malaria falciparum","Malaria infection","Malaria Long-Acting Injectable","Long-Acting Injectable","2026-04-17",{"date":268,"type":41},"2026-04-23",{"date":270,"type":23},"2026-09",{"date":272,"type":23},"2028-03",{"name":274,"class":130},"Medicines for Malaria Venture",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":24,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":49},"100629113","phase-1-a-clinical-study-of-piperaquine-pyronaridine-and-artesunate-administered-in-combination-in-healthy-adults-100629113","NCT07470424","A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults","A Randomized, Open-Label Crossover Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Piperaquine, Pyronaridine and Artesunate in Healthy Adult Participants","APP","Inclusion Criteria:\n\n1. Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.\n2. Male or female non-smoker aged between 18 years to 60 years, weighting between 45 and 85 kg.\n3. A female is eligible to participate in this study if she is:\n\n   * of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy\n   * or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels \\>40 mIU\u002FmL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy\n   * or of childbearing potential, has a negative serum pregnancy test at screening and prior to start the study drug in each period, and agrees to abstain from sexual intercourse or use effective contraceptive methods (e.g., intrauterine device, hormonal contraceptive drug, tubal ligation or female barrier method with spermicide) during the study until completion of the follow-up procedures\n4. Normal electrocardiogram (ECG) with QTc \\\u003C450 msec.\n5. Willingness and ability to comply with the study protocol for the duration of the trial.\n6. Participants is willing and able to give written informed consent for participation in the study\n\nExclusion Criteria:\n\n1. Females who are pregnant, trying to get pregnant, or are lactating.\n2. The participant has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.\n3. A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.\n4. Participants with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of long QT syndrome, Brugada syndrome, or sudden cardiac death.\n5. Abnormal serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) \\\u003C70 mL\u002Fmin as determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n6. History of alcohol or substance abuse or dependence within 6 months of the study.\n7. Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams\u002Fday, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of the investigator, the medication will not interfere with the study procedures or compromise participant safety; the investigator will take advice from the manufacturer representative as necessary.\n8. The participant has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 times the drug half-life, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.\n9. The participant is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen.\n10. Participants who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Note: This does not include plasma donation.\n11. Participants who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during pharmacokinetic sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.\n12. Lack of suitability for participation in this study, including but not limited to, unstable medical conditions, systemic disease manifested by tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus that in the opinion of the investigator would compromise their participation in the trial.\n13. AST or ALT \\>1.5 times the upper limit of normal (ULN)\n14. History of antimalarial drugs use including but not limited to mefloquine, chloroquine, primaquine, artesunate, piperaquine and pyronaridine treatment within 6 months.","60 Years",{"count":285,"type":23},24,[26],"This is an open-label pharmacokinetic study in 24 healthy Thai participants. Participants will be admitted in the inpatient ward and each participant will attend a total of 4 visits, including one screening visit and three hospital admissions. Participants will be randomized into one of six groups.\n\nEach group will receive 3 drug regimens consisting of (1) piperaquine, (2) pyronaridine plus artesunate, or (3) piperaquine, pyronaridine, and artesunate, administered once per day for three consecutive days in different sequential orders.\n\nAfter each regimen, participants will be followed up for six weeks for clinical assessments and laboratory evaluations to study the pharmacokinetics. A washout period of at least eight weeks will be implemented between each regimen.\n\nThis study is funded by the Global Health Innovative Technology Fund (GHIT Fund), Tokyo, Japan, under grant number G2025-117.",[29],"2026-03-30",{"date":291,"type":41},"2026-04-06",{"date":293,"type":23},"2026-06-01",{"date":295,"type":23},"2027-08-01",{"name":297,"class":130},"University of Oxford",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":305,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":308,"conditions":309,"keywords":314,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":4,"leadSponsor":324,"locationsCount":49},"100054640","evaluation-treatment-and-monitoring-of-patients-with-a-known-or-suspected-parasitic-infection-100054640","NCT00001645","Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection","Evaluation, Treatment, and Monitoring of Patients With Known or Suspected Parasitic Infection","* INCLUSION CRITERIA:\n\nAge 3 or over.\n\nAccess to a primary medical care provider outside of the NIH\n\nClinical evidence suggestive of a parasitic infection\n\nEXCLUSION CRITERIA:\n\nLess than 3 years of age\n\nNo evidence suggestive of a parasitic infection","3 Years",{"count":307,"type":23},800,"The purpose of this study is to evaluate, treat and follow patients with parasitic infections.\n\nPeople with a known or suspected parasitic infection who are at least 1 year old may be enrolled. This study does not involve any experimental treatments.\n\nParticipants will have a physical examination and laboratory tests on blood, stool, or urine. Blood samples may be collected at regular intervals, but no more than 450 ml (15 ounces) of blood will be drawn from adults, and no more than 7 ml (1-1\u002F2 teaspoons) per kg (2.2 pounds) of body weight from children, in any 6-week period. Other tests may include x-rays, electrocardiogram (EKG), or tissue biopsy (surgical removal of a small tissue sample), depending on the individual s condition.\n\nPatients may be offered treatment or may be referred to another study that is more appropriate for the problem. Any treatment provided in this study will be according to standard medical practice for the patient s specific medical problem. Patients responses to treatment will be evaluated at regularly scheduled clinic visits. The length of time between visits and the total duration of the study for a given individual will be determined by the study doctor, based on that person s medical condition.",[29,310,311,312,313],"Intestinal Worms","GI Protozoa","Echiniococcus","Strongyloides",[315,316,317,318,69],"Helminth Infection","Parasite","Known Parasitic Infection","Suspected Parasitic Infection","2026-03-13",{"date":321,"type":41},"2026-03-16",{"date":323,"type":41},"1998-10-10",{"name":47,"class":48},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":17,"sex":18,"minAge":333,"maxAge":283,"enrollmentInfo":334,"targetDuration":4,"studyType":24,"phases":336,"briefSummary":337,"conditions":338,"keywords":341,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":76},"100607908","phase-4-r21mm-dosing-presentations-and-preservatives-100607908","NCT07194668","R21\u002FMM Dosing, Presentations, and Preservatives","Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21\u002FMatrix-M - A Noninferiority Trial","VAC100","Inclusion Criteria:\n\n* Residence in a study village for the study period, i.e. 12 months.\n* Age 14 years to 60 years.\n* Written informed consent\u002Fassent provided by participants (or a parent\u002Fguardian in case the participant is under 18 years old).\n\nExclusion Criteria:\n\n* Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.\n* Acute illness requiring intervention.\n* A history of an adverse reaction to study vaccine.\n* Prior receipt of any other malaria vaccine.\n* Enrolment in another intervention trial in the last month.\n* Planned enrolment in another intervention trial in the coming 12 months.\n* Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc. in the past month and\u002For planned for the coming 12 months.","14 Years",{"count":335,"type":23},375,[225],"This is a single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21\u002FMatrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies.\n\nAll participants will receive the same number of injections and will be randomly assigned to receive one of the followings:\n\n* Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21\u002F50μg Matrix-M (n=125).\n* Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21\u002F50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125)\n* Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21\u002F50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125)\n\nClinical procedure for participants:\n\n* Standardized symptom questionnaire\n* Physical examination:\n\nWeight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential)\n\n* Venous blood collection (Pre-vaccination) 3mL\n* Vaccination",[339,29,340],"Plasmodium Falciparum Malaria","Vaccine Reaction",[339,342],"Malaria Vaccine","2026-03-12",{"date":321,"type":41},{"date":346,"type":23},"2026-04-01",{"date":348,"type":23},"2026-12-31",{"name":297,"class":130},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":17,"sex":192,"minAge":193,"maxAge":357,"enrollmentInfo":358,"targetDuration":360,"studyType":60,"phases":4,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":49},"100552071","pregnancy-registry-in-mali-100552071","NCT06468319","Pregnancy Registry in Mali","Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali","Inclusion Criteria:\n\nCommunity Census Cohort:\n\n1. Females of childbearing potential or pregnant females.\n2. Aged 15 to 49 years.\n3. Able to provide verbal individual informed consent.\n\nHealth Facility Cohort:\n\n1. Pregnant females 15 to 49 years and their subsequent offspring.\n2. Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits.\n3. Able to provide written individual informed consent for herself and her future offspring(s).\n\nExclusion Criteria:\n\nCommunity Census Cohort:\n\n1. Temporary residence in the study area.\n2. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.\n\nHealth Facility Cohort:\n\n1. Temporary residence in the study area.\n2. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.","49 Years",{"count":359,"type":23},9500,"5 Years","This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.",[29,363],"Pregnancy Related","2026-03-11",{"date":319,"type":41},{"date":367,"type":41},"2024-08-05",{"date":369,"type":23},"2030-06",{"name":47,"class":48},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":18,"minAge":360,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":24,"phases":381,"briefSummary":382,"conditions":383,"keywords":384,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":389,"leadSponsor":391,"locationsCount":393},"100628967","phase-3-an-ultra-short-course-of-primaquine-for-the-radical-cure-of-vivax-malaria-100628967","NCT07468526","An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria","An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria (PRIMUS)","PRIMUS","Inclusion Criteria:\n\n* P. vivax peripheral parasitaemia as determined by microscopy\n* G6PD normal status (G6PD activity ≥70% of the site specific adjusted male median as determined by the Standard G6PD (SD Bioline, ROK))\n* Fever (temperature ≥37.5°C) or history of fever in the preceding 48 hours,\n* Age ≥5 years\n* Bodyweight ≥14kg\n* Living in the study area and willing to be followed-up for six months\n\nExclusion Criteria:\n\n* Signs or symptoms of severe malaria,\n* Anaemia (defined as Hb \\\u003C8g\u002Fdl) and measured by the Standard G6PD\n* Pregnant or lactating\n* Blood transfusion within the preceding four months\n* Regular or recent use (last month) of tafenoquine, primaquine or dapsone\n* Known hypersensitivity to any of the study drugs",{"count":380,"type":23},1019,[111],"Current treatment regimens to prevent relapsing malaria are too long. A shorter higher dose treatment could improve treatment outcomes, but this needs to be balanced against increased risk of side effects. Recent data from a trial in children in Papua New Guinea (PNG) suggests a shortened treatment of 3 days is safe and effective. Our multicentre trial will assess the safety and efficacy of an ultra-short primaquine course. This trial is expected to directly influence global treatment policies.",[29],[385,377],"An ultra-short course of primaquine for the radical cure of vivax malaria","2026-03-09",{"date":343,"type":41},{"date":293,"type":23},{"date":390,"type":23},"2028-04-01",{"name":392,"class":130},"Menzies School of Health Research",5,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":49},"100624963","effectiveness-of-malaria-vaccines-in-reducing-the-risk-of-invasive-non-typhoidal-salmonella-disease-100624963","NCT07416461","Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease","Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)","VINS","Inclusion Criteria:\n\n1. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR\n2. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation",{"count":403,"type":23},10000,"The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5. Eligible participants residing in the Kisantu Health Zone (DRC) and presenting fever are enrolled in healthcare facilities and tested for malaria and iNTS. Using a case-control (test-negative) design, the researchers will look at the malaria vaccination status of participants with and without iNTS infection to determine if the malaria vaccine protects against iNTS.",[406,29,342],"Invasive Non-Typhoidal Salmonella Disease",[29,408,409,406,410,411,412,413,414],"Vaccine effectiveness","iNTS","DRC","Democratic Republic of Congo","Malaria vaccine","Effectiveness","R21\u002FMatrix-M","2026-02-10",{"date":417,"type":41},"2026-02-18",{"date":419,"type":41},"2025-10-27",{"date":421,"type":23},"2027-02",{"name":423,"class":130},"International Vaccine Institute",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":17,"sex":18,"minAge":360,"maxAge":221,"enrollmentInfo":431,"targetDuration":4,"studyType":24,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":76},"100590446","phase-4-optimizing-malaria-and-hiv-treatment-in-a-shifting-landscape-in-africa-100590446","NCT06967519","OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa","OPTIMAH","Inclusion Criteria:\n\n* Agreement to come to the clinic for all follow-up evaluations\n* Provision of informed consent and assent (as appropriate)\n* Residency within approximately 30 km of the study clinic\n* Negative blood smear for malaria (all sites)\n* For Children and adolescents living with HIV\n\n  * Confirmed HIV infection\n  * On DTG-based regimen for ≥14 days\n* For HIV-uninfected children - documentation of HIV-negative status by at least 1 assay\n\nExclusion Criteria:\n\n* Significant comorbidities such as malignancy, active TB, chronic\u002Factive hepatitis B\u002FC, diabetes, severe acute malnutrition, mitochondrial disorders\n* Receipt of known CYP interacting drugs at enrolment (except HAART) - see list of disallowed medications\n* Anemia defined by hemocue (Hb \\\u003C 7.0) at the time of enrolment\n* Signs of uncomplicated or severe malaria at the time of enrollment\n* Prior intolerance to AL or AS-AQ (for those in Busia only)\n* Pregnancy at enrolment (testing done at enrollment for all those of child-bearing age)\n* Concurrent enrolment in another research study",{"count":432,"type":23},380,[225],"A longitudinal study with four parallel cohorts with each participant followed for 2 years: two cohorts in Busia (high malaria transmission site) and two cohorts in Kampala (low malaria transmission). Each site will have a cohort of children living with HIV (CLHIV) and HIV- uninfected children and will be age-matched, enrolled in parallel, and followed for two years. All children will be enrolled without malaria infection, as determined by a negative blood smear at baseline.",[29,436],"Hiv","2026-02-02",{"date":439,"type":41},"2026-02-04",{"date":441,"type":41},"2025-12-18",{"date":443,"type":23},"2027-12",{"name":445,"class":130},"Yale University",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":17,"sex":18,"minAge":454,"maxAge":193,"enrollmentInfo":455,"targetDuration":4,"studyType":24,"phases":457,"briefSummary":459,"conditions":460,"keywords":461,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":49},"100622724","long-acting-spatial-emanators--repellents-laser-100622724","NCT07387341","Long-acting Spatial Emanators \u002F Repellents (LASER)","Long-acting Spatial Emanators \u002F Repellents (LASER) vs Indoor Residual Spraying (IRS) in Western Kenya: a Cluster-randomised Trial","LASER","The inclusion criteria are:\n\n1. Child aged 1-15 years\n2. Usual resident (a person who has been residing in the survey area for at least the past 4 months) who was present in the sampled household on the night before the survey\n3. Agreement of adult or parent\u002Fguardian (of children) to provide informed consent\n4. Agreement of child aged 12 years or older to provide assent\n\nThe exclusion criterion is:\n\n1\\. Child not at home after 3 attempts","1 Year",{"count":456,"type":23},22815,[458],"NA","Malaria is a major problem in western Kenya, particularly around Lake Victoria. Whilst current prevention methods like bed nets and vaccines help to reduce malaria burden, additional tools are needed to better protect communities from malaria. The investigators will test a new technology called LASER Guardian™, which are devices that release chemicals to keep mosquitoes away from homes. The investigators will conduct a large study involving 69 villages in western Kenya over two years. Each village will be randomly chosen to receive one of three approaches: the new LASER devices, indoor residual spraying with insecticide (a method already known to work), or the standard prevention methods currently used. All villages will continue to receive the usual malaria prevention tools provided by the Kenyan government, including bed nets and vaccines. In villages receiving LASER, the investigators will install 2-3 small device inside structures once a year for two years. In villages receiving IRS, the investigators will spray the inside walls of homes with insecticide once a year for two years. The investigators want to find out if the LASER devices can reduce malaria better than current methods alone, and whether they work as well as indoor spraying. To do this, the investigators will carry out surveys of the community every six months over two years (four rounds in total), testing about 4,485 children between ages 1 and 15 from approximately 3,450 households in each survey to see how many have malaria. The investigators will also work with local health clinics to track malaria cases, study mosquitoes to understand how the interventions affect them, talk with community members about their experiences, and calculate the costs of these different approaches. This study will help us understand whether LASER tool can effectively protecting against malaria in Kenya and other African countries where malaria is common.",[36,257,29],[462,463,464,465],"spatial repellents","spatial emanators","Indoor Residual Spraying","Kenya","2026-01-27",{"date":439,"type":41},{"date":469,"type":23},"2026-01-17",{"date":471,"type":23},"2028-04-30",{"name":473,"class":130},"Liverpool School of Tropical Medicine",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":17,"sex":18,"minAge":481,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":484,"conditions":485,"keywords":543,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":565,"leadSponsor":567,"locationsCount":49},"100620537","risk-assessment-of-community-spread-of-multiple-endemic-infectious-diseases-in-a-one-health-perspective-100620537","NCT07358910","Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective","RACSMEI","Inclusion Criteria:\n\n* Residency in the village for more than 6 months;\n* Age between 2 and 75 years old at the time of inclusion;\n* For adults: provision of written consent;\n* For children aged 2-17 years: written parental consent form, verbal assent from children aged 13-17 years;\n\nExclusion Criteria:\n\n* Unable to understand or consent;\n* Under guardianship or deprived of liberty;\n* Medical conditions that impede survey participation;\n* Refusal to participate in the study.","2 Years","75 Years",{"count":403,"type":23},"RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.\n\nRACSMEI will improve understanding across multiple pathogens using a multidisciplinary One Health approach. We will answer key questions on burden, ecology, transmission and population immune status to inform targeted and culturally appropriate interventions. The project combines a nationally representative One Health survey, social-science methods, and multiplex, diverse diagnostics to efficiently test for 57 priority pathogens, including zoonotic and vector-borne agents, vaccine-preventable and elimination-targeted diseases, enteric, respiratory, and environmentally transmitted pathogens and selected neglected tropical diseases and parasites relevant to Cambodia.\n\nMathematical modelling will reconstruct and forecast transmission dynamics and assess the potential impact of future public-health strategies. By integrating intersectoral data and innovative methods, RACSMEI will generate actionable evidence for public-health authorities, support precision One Health interventions, and help reduce disease burden in affected communities. The project also aims to ensure the transferability of methods and insights to other countries facing similar challenges.",[486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,29,501,502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542],"Dengue","Chikungunya","Zika Virus Infection","Japanese Encephalitis","West Nile Virus","Tick-borne Encephalitis (TBE)","Severe Fever With Thrombocytopenia Syndrome","Nipah Virus Infection","Hantavirus Infections","Hepatitis E","Brucellosis","Q Fever","Leptospirosis","Melioidosis","Influenza A and B","Yellow Fever","Mayaro Fever","Usutu Virus Infection","Oropouche Fever","Rift Valley Fever","Arenavirus Infections","Measles","Mumps","Rubella","Human Papilloma Virus (HPV)","Rotavirus Disease","Pertussis","Diphteria","Tetanus","Varicella","Hepatitis A","Norovirus Infections","Enterovirus","Adenovirus","Rhinovirus","Parvovirus","Respiratory Syncytial Virus (RSV)","Cytomegalovirus","Epstein Barr Virus","Salmonella Typhi","Vibrio Cholerae","Legionella Pneumophila Pneumonia","Mycoplasma","Chlamydia","Lymphatic Filariasis","Toxoplasma Gondii","Giardiasis","Entamoeba Histolytica","Leishmaniasis","Strongyloides Stercoralis Infection","Ascaris Lumbricoides","Trichuris Trichiura","Clonorchis Sinensis","Opisthorchis Viverrini","Schistosomiasis","Streptococcus Pneumoniae","Meningitis",[544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560],"Infectious disease","One Health","Population-based survey","Nationally representative survey","Seroepidemiology","Multiplex serology","Seroprevalence","Vector-borne diseases","Zoonoses","Vaccine-preventable diseases","Neglected tropical diseases","Transmission dynamics","Force of infection","Mathematical modelling","Spatial epidemiology","Precision public health","Cambodia","2026-01-14",{"date":563,"type":41},"2026-01-22",{"date":441,"type":41},{"date":566,"type":23},"2027-09-30",{"name":568,"class":130},"Institut Pasteur du Cambodge",{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":17,"sex":18,"minAge":576,"maxAge":577,"enrollmentInfo":578,"targetDuration":4,"studyType":24,"phases":580,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":76},"100595723","phase-2-a-study-to-assess-the-safety-and-immunogenicity-of-a-vaccine-against-malaria-in-healthy-children-aged-5-60-months-100595723","NCT07036159","A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months","A Phase 2a, Open Label, Randomized, Interventional Study to Assess the Safety and Immunogenicity of Alternative Vaccination Regimens and Reduced Antigen Doses of RTS,S\u002FAS01E Vaccine in Healthy Children Aged 5-60 Months in a Malaria-endemic Area","Inclusion Criteria:\n\n1. Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccinations or for younger infants have received all required vaccinations at point of recruitment according to the schedule for the country where the study is conducted.\n2. Participants' parent(s)\u002FLegally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of the protocol (eg, completion of the diaries, returning for follow-up visits).\n3. Written or witnessed\u002Fthumb-printed informed consent obtained from the participant's parent(s)\u002FLAR prior to performance of any study-specific procedure.\n4. Healthy, as established by medical history and clinical examination.\n5. Negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).\n6. With hemoglobin levels \\>8 g\u002FdL.\n7. Born after a gestation period of ≥37 weeks.\n\nExclusion Criteria:\n\n1. Progressive, unstable, or uncontrolled clinical conditions.\n2. History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.\n3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n4. Clinical conditions representing a contraindication to IM vaccination or blood draws.\n5. Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.\n6. Recurrent history of or uncontrolled neurological disorders or seizures.\n7. Undernutrition, defined as WHO Z-score less than -2 standard deviation.\n8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant as a result of participation in the study, for example, any major congenital defects.\n9. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.\n10. Administration of long-acting immune-modifying drugs (eg, infliximab) during the study period starting 3 months before the first dose of study vaccine or planned administration during the study period.\n11. Prior receipt of a malaria vaccine (registered or experimental).\n12. Use of any investigational or non-registered product (drug, vaccine, or medical device)\\* other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -30 to Day 1), or planned use during the study period.\n\n    \\*Use of herbs and traditional treatments is not considered an exclusion criterion.\n13. Planned administration of a vaccine not foreseen by the study protocol or the country EPI in the period starting 14 days before each dose and ending 28 days after the last dose of study vaccine administration\\*, with the exception of flu vaccines and vaccines administered as part of a public health vaccination campaign\\*.\n\n    \\*If emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided the vaccination is used according to the local governmental recommendations and the Sponsor is notified.\n\n    Under such circumstances, a participant may be considered eligible for study enrollment and\u002For study vaccine administration after the appropriate window for delay has passed, if the participant is confirmed to be eligible after inclusion\u002Fexclusion criteria have been re checked.\n14. Administration of immunoglobulins and\u002For any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.\n15. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this means prednisone ≥0.5 mg\u002Fkg\u002Fday or 20 mg\u002Fday, whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed.\n16. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug or invasive medical device).\n17. Any study personnel's immediate dependents, family, or household members.\n18. Child in care.","5 Months","60 Months",{"count":579,"type":23},238,[167],"The purpose of this study is to evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S\u002FAS01E in healthy children aged 5-60 months in a malaria-endemic area.",[29],[120,584,29,585,586,587],"Plasmodium falciparum","Safety","Immunogenicity","Healthy children","2025-09-24",{"date":590,"type":41},"2025-09-29",{"date":592,"type":41},"2025-08-06",{"date":594,"type":23},"2027-04-23",{"name":596,"class":597},"GlaxoSmithKline","INDUSTRY",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":605,"enrollmentInfo":606,"targetDuration":4,"studyType":24,"phases":608,"briefSummary":609,"conditions":610,"keywords":612,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":49},"100581725","phase-1-a-study-of-oral-e1018-in-healthy-adult-participants-100581725","NCT06854042","A Study of Oral E1018 in Healthy Adult Participants","A First-In-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral E1018 in Healthy Adult Subjects","Inclusion criteria:\n\n1. Nonsmoking\u002Fvaping, male or female, age greater than or equal to (\\>=) 18 years to less than or equal (\\\u003C=) 55 years old at the time of informed consent. To be considered nonsmokers, participant must have discontinued smoking\u002Fvaping for at least 4 weeks before dosing.\n2. Body Mass Index (BMI) \\>=18 and less than (\\\u003C) 30 kilogram per square meter (kg\u002Fm\\^2) at Screening.\n\nExclusion criteria:\n\n1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[β-hCG\\] (or human chorionic gonadotropin \\[hCG\\]) test with a minimum sensitivity of 25 international units per liter (IU\u002FL) or equivalent units of β-hCG \\[or hCG\\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the dose of study drug.\n2. Females of childbearing potential. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).\n3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method, as described below, throughout the study period and for 28 days after study drug discontinuation. If the female partner is pregnant, then males who do not agree to use latex or synthetic condoms throughout the study period and for 28 days after study drug discontinuation. No sperm donation is allowed during the study period and for 28 days after study drug discontinuation. The duration may be expanded further based on the half-life of the study drug calculated in this study.\n\n   • A highly effective method of contraception includes any of the following:\n   * total abstinence (if it is their preferred and usual lifestyle)\n   * an intrauterine device or intrauterine hormone-releasing system\n   * a contraceptive implant\n   * an oral contraceptive (the participant's partner must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of oral contraceptive throughout the study and for 28 days after study drug discontinuation). It is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant's partner, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical\u002Fvault cap with spermicide. The duration of contraception period may be extended based on the half-life of the study drug calculated in this study.\n4. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.\n5. Presence of concurrent febrile illness(es) at Screening or Baseline.\n6. Any history of surgery that may affect PK profiles of E1018 (example, hepatectomy, nephrectomy, digestive organ resection) or participants who have a congenital abnormality in metabolism at Screening.\n7. Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline.\n8. Left bundle branch block.\n9. History of myocardial infarction, active ischemic heart disease, or clinically significant or uncontrolled arrhythmia.\n10. Known history of clinically significant drug allergy at Screening.\n11. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening.\n12. Known to be human immunodeficiency virus (HIV)-positive at Screening.\n13. Active viral hepatitis (A, B or C) as demonstrated by positive serology at Screening.\n14. History of drug or alcohol dependency or abuse, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline.\n15. Currently enrolled in another clinical study or used any investigational drug or device within 30 days or 5 half-lives (whichever is longer) preceding informed consent.\n16. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing.\n17. A history of noncompliance in any previous study or inability to comply with study conduct, as assessed by the investigator.\n18. Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the study.","55 Years",{"count":607,"type":23},32,[26],"The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy adult participants and to evaluate the pharmacokinetics (PK) of E1018 in plasma and urine after single oral dose administration.",[29,611],"Healthy Participants",[613],"E1018","2025-09-19",{"date":588,"type":41},{"date":617,"type":41},"2025-02-26",{"date":619,"type":23},"2025-12-23",{"name":621,"class":597},"Eisai Inc.",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":630,"enrollmentInfo":631,"targetDuration":4,"studyType":24,"phases":633,"briefSummary":634,"conditions":635,"keywords":639,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":76},"100599262","phase-3-monoclonal-antibodies-in-children-with-severe-anaemia-or-severe-malaria-to-prevent-malaria-after-hospital-discharge-100599262","NCT07082205","Monoclonal Antibodies in Children With Severe Anaemia or Severe Malaria to Prevent Malaria After Hospital Discharge","Single-Use Antimalarial Monoclonal Antibodies for Post-Discharge Malaria Prevention in Children With Severe Anaemia or Severe Malaria in Kenya: A Multi-Centre, Parallel-Group, Two-Arm Randomised Placebo-Controlled Non-Inferiority Trial","L9LS-pd","Inclusion Criteria:\n\nInclusion criteria for enrolment into the pre-study screening period\n\n* Aged \\\u003C10 years of both sexes\n* Severe anaemia or severe malaria: Initially hospitalised with haemoglobin \\\u003C5.0 g\u002Fdl or PCV \\\u003C15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and the presence of microscopy or RDT confirmed Plasmodium infection\n* Resident in catchment area\n\nEligibility criteria for enrolment\n\n* Fulfilled the pre-study screening eligibility criteria\n* Post-transfusion haemoglobin \\>=5.0 g\u002Fdl or PCV \\>=15%\n* Clinically stable, able to take oral medication, able to feed (for breastfeeding children) or eat (for older children) and able to sit unaided (for older children who were already able to do so before hospitalisation)\n* Provision of informed consent by parent or guardian Exclusion criteria for enrolment into the pre-study screening period\n\nExclusion Criteria:\n\nExclusion criteria for enrolment into the pre-study screening period\n\n* Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)\n* Sickle cell anaemia\u002Fsickle cell disease\n* Body weight \\\u003C5 kg\n* HIV infection or on daily cotrimoxazole prophylaxis\n\nExclusion criteria for enrolment\n\n* Previous enrolment in the present study\n* Children who are scheduled to receive any of the four doses of the malaria vaccine within 6 months after enrolment.\n* Received any RTS,S or R21 malaria vaccine primary series or booster dose within the last 14 days inclusive\n* On or eligible for cotrimoxazole prophylaxis for HIV infection or HIV exposure\n* Children with sickle cell disease because they are eligible for daily proguanil\n* Known hypersensitivity to artemether-lumefantrine or dihydroartemisinin-piperaquine\n* Anticipated to reside for more than 1 month of the 6-month (26 weeks) intervention period outside of the catchment area (e.g. boarding school)\n* Use or known need at enrolment for concomitant prohibited medication during the first 6 months post-discharge\n* Ongoing or planned participation in another clinical trial involving ongoing or scheduled treatment with prohibited medicinal products or active follow-up during the first 26 weeks post-discharge\n* A known need at the time of enrolment for scheduled surgery during the first 6 months post-discharge\n* Suspected non-compliance with the follow-up schedule and protocol in the opinion of the investigator\n* Known heart conditions or family history of congenital prolongation of the QTc interval, or taking medicinal products that are known to prolong the QTc interval","9 Years",{"count":632,"type":23},398,[111],"Background and rationale: Hospitalised children with severe anaemia remain at high risk of dying or requiring hospital readmission for at least 6 months after discharge. In highly malaria-endemic settings, malaria is a major contributor to these post-discharge readmissions and deaths. In 2022, the World Health Organisation (WHO) recommended post-discharge malaria chemoprevention (PDMC) for children hospitalised with severe anaemia living in malarious areas. Kenya, together with several other countries in sub-Saharan Africa, aims to expand WHO's recommendation and introduce PDMC in children hospitalised with severe anaemia or severe malaria, including children with severe malaria who do not have severe anaemia (e.g. cerebral malaria). PDMC consists of full 3-day treatment courses with long-acting antimalarials given monthly three times after discharge. PDMC is very effective in clinical trials. However, adherence to these monthly 3-day drug treatments is limited under real-life conditions. Furthermore, PDMC provides chemoprevention for about 3.5 months only, while the risk of dying or needing to be readmitted remains high for several more months.\n\nThe US National Institutes of Health (NIH) has developed two monoclonal antibodies targeting Plasmodium falciparum malaria (mMAb). These proteins specifically target a highly conserved epitope found on the circumsporozoite protein-1 (CSP-1) of P. falciparum to neutralize it and prevent malaria infection. A key feature of mMAbs is that they can provide protection for up to 6 months with a single dose and thus serve as a \"long-acting\" drug. Recent placebo-controlled studies in healthy adults in Mali suggest that the first mMAb, CIS43LS, when administered at a dose of 40 mg\u002Fkg intravenously (IV), can block 88% of malaria infections for at least 6 months. More recently, studies with a newer mMAb called L9LS, which is anticipated to be more potent than CIS43LS, showed a 74% reduction in uncomplicated clinical malaria by 6 months when administered subcutaneously to healthy Malian children aged 6-10 years by a single subcutaneous (SC) dose of 10-20 mg\u002Fkg (NCT05304611). Similar studies with L9LS are ongoing in healthy children under 5 years of age in Siaya, western Kenya (NCT05400655).\n\nYoung children admitted to hospitals in highly malaria-endemic areas with severe anaemia or severe malaria are an ideal target group for passive immunoprevention with mMAbs as a single infusion with mMAb while in the hospital could protect this high-risk group during the entire vulnerable post-discharge period.\n\nOverview design: investigators will conduct a 2-arm, multi-centre, individually randomised, placebo-controlled non-inferiority trial in 398 children with severe malaria or severe anaemia. Children will be randomly assigned (1:1) using minimum sufficient balance (MSB) randomisation to receive either mMAb before discharge or 3 courses of monthly PDMC after discharge, according to WHO guidelines. The study will be placebo-controlled. Children in the PDMC arm will receive a placebo infusion with normal saline before discharge; children in the mMAb arm will receive placebo-PDMC. All children will receive standard in-hospital care, including a blood transfusion and treatment for severe malaria where indicated. They will also receive a full 3-day treatment course with the antimalarial artemether-lumefantrine (AL) to clear any existing malaria infections as soon as they have recovered and can take oral medication.\n\nThe primary endpoint is the incidence of clinical malaria detected by passive case detection by 6 months post-discharge (the intervention period). Key secondary endpoints include the rates of readmissions and deaths (all children). Children will be followed for another 6 months (post-intervention period) to determine the duration of protection, any long-term impact (e.g., growth) and if mMAbs result in a delayed acquisition of natural protective immunity against clinical malaria Study Interventions: All children will receive standard in-hospital care, including a blood transfusion, antibiotics, and treatment for severe malaria where indicated. All children in both arms will be empirically treated for malaria infection around discharge with a 3-day regimen with artemether-lumefantrine to ensure parasite clearance of any existing parasites. Participants in the mMAb arm will receive the study agent L9LS IV with a target dose of 30 mg\u002Fkg. The IV dose will use 1 kg step increases. During the 6-month intervention period, children in the placebo-mMAbs arm will receive three courses of monthly PDMC as per WHO guidelines with dihydroartemisinin-piperaquine (DP) at 2, 6 and 10 weeks post-discharge. Those in the mMAbs arm will receive an identical placebo PDMC",[29,636,637,638],"Severe Malaria","Severe Anaemia","Post Discharge",[640,641,642,643,644,645,646],"monoclonal antibodies","malaria","post-discharge","prevention","severe anaemia","severe malaria","children","2025-07-14",{"date":649,"type":41},"2025-07-24",{"date":651,"type":41},"2025-05-02",{"date":653,"type":23},"2027-04",{"name":473,"class":130},{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":17,"sex":192,"minAge":663,"maxAge":664,"enrollmentInfo":665,"targetDuration":4,"studyType":24,"phases":667,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":49},"100511044","l-arginine-to-prevent-adverse-pregnancy-outcomes-agree-100511044","NCT05934318","L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)","Oral Antenatal L-citrulline Supplementation to Reduce Adverse Pregnancy Outcomes: a Two-arm, Randomized, Placebo-controlled Multi-site Trial in Kenya","AGREE","Inclusion Criteria:\n\n* Pregnant women aged 16-40 years,\n* inclusive to 24 weeks gestational age as confirmed by ultrasound,\n* who have a viable singleton pregnancy,\n* are residents of the study area,\n* willing to adhere to scheduled and unscheduled study visit procedures,\n* willing to deliver in a study clinic or hospital\n\nExclusion Criteria:\n\n* multiple pregnancies (i.e. twin\u002Ftriplets);\n* pre-existing hypertension, renal disease and\u002For diabetes, or severe anaemia (Hb \\\u003C 5 g\u002FdL);\n* HIV-positive or HIV status unknown;\n* malformations or nonviable pregnancy observed on enrolment ultrasound;\n* known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet;\n* unable to give consent; or concurrent participation in any other clinical trial","16 Years","40 Years",{"count":666,"type":23},2960,[458],"There are few safe, effective, and affordable interventions to improve pregnancy outcomes in low resource settings where the highest rates of poor birth outcomes occur. L-citrulline is naturally found in many foods and is changed into another important amino acid, L-arginine, in the body. L-arginine is important for the growth of a healthy placenta and healthy baby. Adding L-citrulline to the diets of pregnant women may be an effective and affordable way to improve the health of their babies.The goal of the AGREE trial is to test whether a dietary supplement containing a common food component, an amino acid called L-citrulline, can help pregnant Kenyan women at risk of malaria have healthier pregnancies and healthier babies. 2,960 pregnant Kenyan women will be enrolled and randomly assigned to take either a twice daily dietary supplement containing L-citrulline or a placebo supplement without additional L-citrulline. Maternal participants will be seen every month until delivery and at weeks 1 and 6 after birth. Infants will also be followed up at ages 6, 12, 18, and 24 months. The primary outcome of the study is 'adverse pregnancy outcome', a composite of foetal loss (miscarriage or still birth), preterm birth, low birth weight, small for gestational age or neonatal mortality. The results of the AGREE trial could help to guide obstetric and public health policy and provide a sustainable solution that could be implemented at the community level.",[670,29,671,672,673,674],"Pregnancy","Nutrition","Placental Development","Preterm Birth","Fetal Growth Restriction","2025-06-24",{"date":677,"type":41},"2025-06-27",{"date":679,"type":41},"2023-12-29",{"date":681,"type":23},"2026-12-30",{"name":473,"class":130},{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":689,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":24,"phases":693,"briefSummary":694,"conditions":695,"keywords":697,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":49},"100499810","phase-4-act-vs-cq-with-tafenoquine-for-p-vivax-mono-infection-100499810","NCT05788094","ACT vs CQ With Tafenoquine for P. Vivax Mono-infection","Does Artemisinin Combination Treatment Reduce the Radical Curative Efficacy of High Dose Tafenoquine for Plasmodium Vivax Malaria?","ACTQ","Inclusion Criteria:\n\n* Patients with P. vivax mono-infection as diagnosed by Rapid Diagnostic Test\n* Fever or history of fever in the previous 7 days\n* Quantitative G6PD activity ≥70% of the population median i.e., ≥6.1U\u002FgHb\n* Age \\> 18 years, Weight \\>35 kg\n* Ability to understand the study instructions and provide informed consent\n* Willing to be followed for 4 months and likely to adhere to the study protocol.\n\nExclusion Criteria:\n\n* Coincident P. falciparum malaria or other infections\n* Pregnancy\n* Lactation\n* Hb \\\u003C 8 g\u002FdL\n* Quantitative G6PD activity \\\u003C70% of the population median i.e., \\\u003C6.1U\u002FgHb\n* Severe malaria (as per WHO guideline)\n* History of allergic or haemolytic response to any of the study drugs",{"count":692,"type":23},606,[225],"In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020 ASTMH Annual Meeting) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019 NEJM; Watson et al. 2022a Elife). A tafenoquine dose of 450mg is predicted to provide \\>90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.",[29,696,114],"Malaria, Vivax",[698,699,700,29],"artemisinin combination treatment","tafenoquine","Plasmodium vivax malaria","2025-05-13",{"date":703,"type":41},"2025-05-16",{"date":705,"type":41},"2023-06-26",{"date":707,"type":23},"2026-08-31",{"name":709,"class":130},"Shoklo Malaria Research Unit",{"id":711,"slug":712,"hasResults":12,"nctId":713,"briefTitle":714,"officialTitle":715,"acronym":716,"eligibilityCriteria":717,"healthyVolunteers":12,"sex":18,"minAge":718,"maxAge":719,"enrollmentInfo":720,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":722,"conditions":723,"keywords":724,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":728,"lastUpdatePostDateStruct":729,"startDateStruct":731,"completionDateStruct":733,"leadSponsor":735,"locationsCount":737},"100442451","strengthening-the-evidence-for-policy-on-the-rtssas01-malaria-vaccine-100442451","NCT05041556","Strengthening the Evidence for Policy on the RTS,S\u002FAS01 Malaria Vaccine","Strengthening the Evidence for Policy on the RTS,S\u002FAS01 Malaria Vaccine: Assessment of Safety and Effectiveness Using Case-control Studies Embedded in the Malaria Vaccine Pilot Evaluation","MVPE-CC","Inclusion Criteria:\n\n* Willingness to participate in study evidenced by written informed consent provided by an adult caregiver\n* Resident in an RTS,S\u002FAS01 implementation area within the catchment area of MVPE sentinel hospitals\n* Eligible, based on date of birth and age, to have received RTSS\u002FAS01\n* Meets the case or control definitions above.\n\nExclusion Criteria:\n\n* Caregiver not willing to provide consent","6 Months","59 Months",{"count":721,"type":23},9280,"The ongoing Malaria Vaccine Pilot Evaluation (MVPE) is being conducted in Ghana, Malawi and Kenya through community and sentinel hospital surveillance systems and a series of household surveys (to measure vaccine coverage). The Malaria Vaccine Pilot Evaluation-Case Control (MVPE-CC) registered here as observational study is embedded within MVPE comprising case-control studies of clinical and mortality outcomes. Each case will require four controls, and caregiver informed consent will be required prior to study activities.\n\nThese observational case control studies will measure as complementary information to what is being collected through MVPE:\n\n1. Safety among children who received the malaria vaccine, with focus on cerebral malaria, meningitis and severe malaria\n2. The impact of the malaria vaccine on all-cause mortality for boys and girls, AND\n3. Promote use of case-control approaches by Expanded Programmes on Immunization (EPI) and malaria control programmes.",[29],[29,725,726,585,727],"Vaccines","Case-control","Mortality","2025-02-25",{"date":730,"type":41},"2025-02-28",{"date":732,"type":41},"2021-10-18",{"date":734,"type":23},"2025-04-30",{"name":736,"class":130},"Kintampo Health Research Centre, Ghana",4,{"id":739,"slug":740,"hasResults":12,"nctId":741,"briefTitle":742,"officialTitle":742,"acronym":743,"eligibilityCriteria":744,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":745,"targetDuration":4,"studyType":24,"phases":747,"briefSummary":748,"conditions":749,"keywords":751,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":756,"lastUpdatePostDateStruct":757,"startDateStruct":759,"completionDateStruct":761,"leadSponsor":763,"locationsCount":4},"100575248","host-immunity-plasmodium-and-pathogens-co-infections-100575248","NCT06769815","Host Immunity, Plasmodium and Pathogens Co-Infections","HIPPI","Inclusion Criteria:\n\nFebrile children:\n\n* aged between 6 and 60 months\n* with a febrile episode lasting less than 7 days (axillary temperature \\>=37.5° Celsius)\n* whose state of health is compatible with a minimum single blood sample volume of 6.25 ml\n\nNon-febrile children:\n\n* aged between 6 and 60 months\n* with axillary temperature \\\u003C37.5° Celsius\n* no clinical signs of infection at the time of inclusion\n* no infectious episode or fever for 7 days\n\nPregnant women :\n\n* giving birth in the project's partner health center\n* intending to reside in the study area during the newborn follow-up period\n* with a mono-fetal pregnancy\n* With an apparently uncomplicated delivery not requiring referral to a higher-level health facility\n\nNewborns at delivery:\n\n* Born at term (determined by Ballard score)\n* whose parents or legal guardians reside in the study area during the newborn's follow-up period\n\nExclusion Criteria:\n\nFor all :\n\n\\- person already participating in another biomedical research project.\n\nFor febrile and non-febrile children:\n\n\\- chronic non-infectious pathology (cancer, malnutrition, etc.)\n\nFor pregnant women\n\n* scheduled caesarean section for current pregnancy\n* Caesarean section in previous pregnancies\n* chronic non-infectious pathology during pregnancy (diabetes, hypertension, pre-eclampsia)",{"count":746,"type":23},2000,[458],"Few studies have focused on malaria co-infections, mainly caused by Plasmodium falciparum, occurring mainly in children under 5 years of age in sub-Saharan Africa. These studies have focused on malaria-associated bacterial sepsis, with an estimated prevalence of 9.1% and associated mortality of 15.0%. However, no study has documented infectious sites other than the blood compartment, considered viruses and parasites as possible causes of infection in addition to bacteria, and used molecular diagnostic methods based on PCRs, which are more sensitive. Thus, the prevalence of these co-infections and the spectrum of pathogens involved are probably underestimated, as is the impact of these co-infections on mortality. Furthermore, it has been shown that malaria infections can condition the immune cells of naturally exposed individuals, potentially leading to greater susceptibility to all types of infection. But these mechanisms have never been documented in the context of co-infections.\n\nThe WHO recommends the use of broad-spectrum antibiotics in cases of severe malaria, in addition to antimalarial drugs, as it can be difficult to differentiate clinically between severe malaria and severe bacterial infection (bacteremia, pneumonia and meningitis). Yet this empirical use of antibiotics could be contributing to an increase in antibiotic resistance. Identifying the determinants of co-infection with malaria and severe bacterial infection would enable this treatment to be better targeted.\n\nThese determinants remain undetermined as no study has considered other causes of severe bacterial infection other than bacteremia, used appropriate statistical methodology (univariate analysis only) and explored important determinants, notably the capacity of children's innate immunity to respond to severe bacterial infection.",[29,750],"Bacterial Co-infection",[641,752,753,754,646,755],"co-infection","immune response","epigenetic mechanisms","Togo","2025-01-21",{"date":758,"type":41},"2025-01-24",{"date":760,"type":23},"2025-02-15",{"date":762,"type":23},"2027-08-15",{"name":764,"class":597},"Institut Pasteur"]