[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Tropical Medicine, Belgium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":465},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,36,64,89,119,145,171,205,235,257,287,312,340,371,395,419,439],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":4},"100645378","clinical-validation-of-isothermal-nucleic-acid-amplification-bioassays-modules---guinea-100645378",false,"NCT07681752","Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA","Inclusion Criteria:\n\n* EBOV and LASV test positive and negative biobanked patient samples\n\nExclusion Criteria:\n\n* not applicable","ALL",{"count":17,"type":18},150,"ESTIMATED","OBSERVATIONAL","This study aim to validate the clinical performances of two newly developed isothermal nucleic acid amplification bioassays modules for EBOV and LASV. Two retrospective studies will be conducted using biobanked patient samples such as plasma samples and buccal swabs already collected by the Centre de Recherche en Virologie, Laboratoire des Fièvres Hémorragiques Virales de Guinée (CRV-LFHVG) as part of their surveillance and outbreak activities. The diagnostic sensitivity and specificity of the EBOV and LASV bioassays modules will be compared to the gold-standard reverse transcriptase polymerase chain reaction (RT-PCR) technologies used in the national reference lab.",[22,23],"Ebola Hemorrhagic Fever","Lassa Hemorrhagic Fever","NOT_YET_RECRUITING","2026-06-30",{"date":27,"type":28},"2026-07-02","ACTUAL",{"date":30,"type":18},"2027-01",{"date":32,"type":18},"2027-12",{"name":34,"class":35},"Institute of Tropical Medicine, Belgium","OTHER",{"id":37,"slug":38,"hasResults":11,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":4,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":15,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100643808","baseline-assessment-of-skin-resident-memory-t-cells-in-healthy-unvaccinated-participants-100643808","NCT07636551","Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants","Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants (GeKoSkimm-Unvaccinated): add-on Study to the GeKoSkimm Trial (= A Randomized Controlled Trial to Compare the Immunogenicity and Skin Imprinting of Intradermal, Subcutaneous and Intramuscular Yellow Fever Vaccination)","Inclusion Criteria:\n\n* BMI \\>\u002F=18,5 kg\u002Fm2 and ≤35 kg\u002Fm2\n* Agreement to share and discuss participant's medical history and medical records when relevant with the study team\n* Able and willing to provide written informed consent\n* Agreement to refrain from blood donation and other vaccinations during the study\n\nExclusion Criteria:\n\n* Participants with a confirmed flavivirus infection in the past\n* Participants who received a flavivirus vaccination prior to enrolment (e.g. YFV, Japanese encephalitis virus, tick-borne encephalitis virus, Dengue)\n* Receipt of any vaccine (licensed or experimental) within 30 days prior to enrolment or during the study\n* Active participation in another interventional clinical study with active substance intake or large medical procedures affecting the study procedures during or 1 month prior to enrolment\n* Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the visit; inclusion at a later date is permitted at the discretion of the investigator\n* Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer and human immunodeficiency virus\u002Fhepatitis B virus infection); asplenia; recurrent severe infections and use of immunosuppressant medication (including antineoplastic and immunomodulating agents or radiotherapy) within the last 6 months prior to enrolment, except topical or short-term oral steroids (\\\u003C2 weeks of daily receipt of 20 mg of prednisone or equivalent). Refer to annex 1 for a list of immunosuppressive medication\n* Severe and\u002For uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, psychiatric and neurological illness (mild\u002Fmoderate well controlled comorbidities are allowed)\n* History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following venipuncture\n* Any significant disease, disorder or planned surgery which may affect the ability of the volunteer to participate in the study or impact (skin) immunity homeostasis\n* Suspected or known alcohol or drug dependency\n* Known pregnancy\n* Tendency to keloid (scar) formation in response to skin damage\n* Skin diseases or tattoo at the biopsy site\n* In the opinion of the investigator, unlikely compliance to the requirements of the study\n* History of thymus dysfunction (including myasthenia gravis, thymoma) or thymectomy\n* Individuals who are working at the investigational site or within the research team of this study\n* Participants who received immunoglobulins and\u002For any blood or blood derived products within 3 months preceding the study\n* Participants who are currently on anticoagulant therapy\n* Participants who are continuously using systemic antivirals",true,"18 Years","50 Years",{"count":47,"type":18},40,"INTERVENTIONAL",[50],"NA","In The main GeKoSkimm trial (= A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal, subcutaneous and intramuscular yellow fever vaccination) the investigators try to understand whether the route of injection (in the muscle, under the skin, or in the skin) when giving the yellow fever vaccine affects the strength of the body's immune response to yellow fever. More in particular the investigators want to know how well the immune responses are retained in the skin, as this is the place where the virus enters the body after a mosquito bite. This will be important for vaccines against infections transmitted via bites of mosquitoes and ticks, such as yellow fever virus. Because this is the first attempt on human samples and only skin samples after vaccination with yellow fever vaccine are available, the investigators want to assess the baseline or background immune response in 'unvaccinated' skin. Therefore, 40 volunteers will be recruited that have not been previously vaccinated against yellow fever and will not receive a yellow fever vaccine during this study. The participant will be requested to provide two skin samples from the upper arm and a blood sample to confirm their vaccination status regarded to yellow fever.",[53,54],"Yellow Fever (Healthy Volunteers)","Biopsy\u002FMethods","2026-06-08",{"date":57,"type":28},"2026-06-09",{"date":59,"type":18},"2026-06-15",{"date":61,"type":18},"2026-11-15",{"name":34,"class":35},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":43,"sex":15,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":48,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":63},"100485146","phase-3-bedaquiline-enhanced-post-exposure-prophylaxis-for-leprosy-100485146","NCT05597280","Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy","Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study","BE-PEOPLE P3","Inclusion Criteria:\n\n1. Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health\n2. Aged 2 years and above, as leprosy is very rare among infants and young toddlers. Children age 2-4 years or weighing less than 20 kg will not be given bedaquiline. If eligible they will receive only rifampicin.\n3. Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)\n\nExclusion Criteria:\n\n1. Signs of active leprosy\n2. Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)\n3. Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)\n4. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period\n5. Self-reported (suspected) pregnancy or breastfeeding\n6. Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)","2 Years",{"count":74,"type":18},124000,[76],"PHASE3","There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg\u002Fkg of rifampicin in a single dose. In both arms the investigators will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received BE-PEOPLE standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the investigators will compare the overall leprosy incidence over the follow-up period between the two study arms.",[79],"Leprosy","RECRUITING","2026-05-18",{"date":83,"type":28},"2026-05-19",{"date":85,"type":28},"2023-03-22",{"date":87,"type":18},"2027-03-15",{"name":34,"class":35},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":15,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":63},"100606368","testing-of-a-new-rapid-antigen-test-for-plague-in-ituri-democratic-republic-of-the-congo-100606368","NCT07174648","Testing of a New Rapid Antigen Test for Plague in Ituri, Democratic Republic of the Congo.","Field Evaluation of a Novel Antigen Rapid Diagnostic Test for Plague in the Province of Ituri, DR Congo","RAPID-IT","Inclusion Criteria:\n\n* All participants (aged ≥5 year old) within Rethy, Logo and Aru health zones, presenting with possible symptoms of bubonic and\u002For pneumonic plague according to WHO definition\n* Willing to provide voluntary consent (or voluntary assent and parental consent in case of minors.\n\nExclusion Criteria:\n\n* Participants not eligible, able, or willing to undergo study procedures\n* Children \\\u003C5 years of age\n* Participants on antibiotic treatment ≥48h prior to recruitment","5 Years",{"count":99,"type":18},300,"This study is being done to learn more about the disease in Ituri and to evaluate a new rapid test that may help doctors find the disease more quickly. This research includes characterisation of clinical presentations and pathology of plague, as well as identification of circumstances that may increase the risk of infection. Biological samples collected include blood, mouth swab, saliva, a bubo aspirate and a sputum sample (the latter only in case of plague in the lungs). These samples will be used to test the performance of the new rapid study test.",[102,103,104],"Plague","Bubonic; Plague, Skin","Plague, Pneumonic",[102,106,107,108,109,110],"Bubonic Plague","Pneumonic Plague","Ituri","DRC","Antigen rapid diagnostic test","2026-03-24",{"date":113,"type":28},"2026-03-27",{"date":115,"type":18},"2026-05-01",{"date":117,"type":18},"2029-01-02",{"name":34,"class":35},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":15,"minAge":44,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":144,"locationsCount":63},"100630413","recurrent-visceral-leishmaniasis-in-hiv-co-infection-100630413","NCT07487350","Recurrent Visceral Leishmaniasis in HIV Co-Infection","New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study","ALIVE","Inclusion Criteria:\n\n1. VL-HIV infection 1.1. VL: microscopically confirmed parasite presence in spleen or bone marrow tissue at first episode or relapse; for known active chronic cases: decision to treat VL 1.2. HIV: confirmed viral infection (new or past)\n2. ≥18 years\n\nExclusion Criteria:\n\n1. Not willing to provide written informed consent\n2. Not willing to adhere to the follow-up visits\n3. Mentally or physically incapable to participate in the study (to the discretion of the treating physician)",{"count":128,"type":18},20,"The aim is (1) to better understand the underlying causes and predispositions for relapse and parasite persistence in visceral leishmaniasis (VL) patients living with HIV and (2) to improve treatment monitoring of this target group in Ethiopia",[131,132],"Hiv","Visceral Leishmaniasis",[134,135,136,137],"HIV","VL","VL Relapse","Immune exhaustion","2026-03-17",{"date":140,"type":28},"2026-03-23",{"date":142,"type":28},"2025-10-21",{"date":32,"type":18},{"name":34,"class":35},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":15,"minAge":44,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":63},"100506867","prospective-study-for-the-follow-up-of-human-monkeypox-cases-and-smallpox-vaccinees-at-risk-100506867","NCT05879965","Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk","Prospective On-site and Questionnaire Study for the FOLLOW-UP of Mpox Cohort at ITM PLUS Evaluation of the Longevity of B- and T-cell Immune Responses in Former Mpox Patients and Vaccine Recipients","POQS-FU PLUS","Mpox patients for immunological study\n\nInclusion criteria\n\n* PCR-confirmed mpox infection since May 2022\n* ≥18 years\n* Willingness to provide written informed consent\n* Willingness to follow the study schedule\n\nExclusion criteria\n\n* Any vaccination 2 weeks before or after the visits (4 weeks for life-vaccines)\n* Any immune-compromising drugs or diseases (treated and controlled HIV-infection is no exclusion criteria)\n* Any mpox reinfection since study start\n\nSmallpox vaccinees for immunological study\n\nInclusion criteria\n\n* At least two smallpox vaccinations.\n* ≥18 years\n* Willingness to provide written informed consent\n* Willingness to follow the study schedule\n\nExclusion criteria\n\n* Any vaccination 2 weeks before or after the visits (4 weeks for life-vaccines)\n* Any immune-compromising drugs or diseases (treated and controlled HIV-infection is no exclusion criteria)\n* Any mpox infection in the past\n\nHIV-Prep patients\n\nInclusion criteria\n\n* On HIV-PrEP and a patient from ITM\n* ≥18 years\n* Willingness to provide written informed consent\n* Willingness to follow the study schedule\n\nExclusion criteria\n\n* Born before 1976\n* Any documented or remembered smallpox vaccination or typical scar for a smallpox vaccination\n* Any vaccination 2 weeks before or after the visits (4 weeks for life-vaccines)\n* Any immune-compromising drugs or diseases\n* Any mpox infection in the past",{"count":154,"type":18},345,"The goal of this observational study is to describe possible physical and psychological sequelae after an mpox infection and to evaluate the longevity of B- and T-cell immune responses in former mpox patients and vaccine recipients.\n\nThe main questions it aims to answer are:\n\n* Are there any physical or pschological sequelae after mpox infection?\n* Is the humoral and\u002For cellular immune response to MPOX (or vaccinia) virus) durable?\n* Do the patients develop strong local immunity in comparison to systemic immunity?\n* How long is the virus still detectable in semen, saliva or the ano-rectal region?\n\nParticipants will answer a questionnaire, samples with blood, saliva and semen as well as anal swabs will be collected. Follow-up visits 8, 16 and 24, 36, 48, and 60 months after infection or vaccination are planned.\n\nA healthy control group will be recruited in our HIV-PrEP clinic.",[157],"Monkeypox",[159,160,161,162,163],"mpox","immunology","mucosal immunity","sequelae","smallpox vaccination",{"date":165,"type":28},"2026-03-19",{"date":167,"type":28},"2022-10-06",{"date":169,"type":18},"2028-06",{"name":34,"class":35},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":15,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":48,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},"100628546","phase-3-study-comparing-several-drugs-to-understand-which-work-against-cutaneous-leishmaniasis-cl-100628546","NCT07463040","Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL)","A Multi-Arm, Multi-Stage Randomized Controlled Clinical Trial Evaluating Systemic Therapeutic Regimens for the Treatment of Cutaneous Leishmaniasis in Ethiopia","Inclusion Criteria:\n\n* Parasitological (microscopy, culture or PCR) confirmation of leishmaniasis\n* Age ≥4 and ≤65 years old\n* Need systemic treatment based on meeting at least one of the following criteria: \\>4 lesions\u002F At least one with lesion size \\>4cm\u002F Mucosal involvement, or at risk for mucosal involvement (\\\u003C1 cm from the nose, eyes or vermillion border of the lips)\u002F Previous failure of lesion-directed treatment \u002FLesions on areas not suitable for lesion-directed therapy (e.g. joints, eyelids, fingers)\u002F Deep or extensive lesion(s) with risk of functional impairment\n* Informed consent provided, as follows: For patients ≥18 years of age: Patient is willing and able to provide informed consent. \u002F For patients aged 8 to 17 years (inclusive): Parent or caregiver is willing and able to provide informed consent, and patient is willing and able to provide assent \u002F For patients aged 4 to 7 years (inclusive): Parent or caregiver is willing and able to provide informed consent.\n* Willing and able to be hospitalized for the duration of treatment\n* Willing and able to attend all follow-up visits\n* If female and of child-bearing age: willing to take contraceptives during treatment and for 5 months after EoT (parenteral, intrauterine device (IUD) or implant). Note that actually taking the contraceptives is only required when randomized in an investigational arm containing miltefosine.\n\nExclusion Criteria:\n\n* Pregnant (positive pregnancy test at screening) or breastfeeding\n* Any known severe medical comorbidities, or signs and symptoms of severe disease, that in the opinion of the investigator disqualifies the patient of being enrolled in the trial or precludes evaluation of the patient's response to the study medication. Examples are: Severe known active infections such as tuberculosis, schistosomiasis, malaria, hepatitis B virus, active hepatitis C virus\u002F Serious underlying disease (e.g. cardiac, renal, hepatic (including diabetes mellitus) or chronic disease\u002F Immunocompromising conditions: transplant patients, or patients receiving immunosuppressant medication\u002F Pre-existing ocular conditions evaluated at baseline: e.g. keratitis, uveitis, scleritis\u002F Pre-existing sensorineural hearing loss evaluated at baseline, or previously diagnosed with ototoxicity\n* HIV Infection\n* Severe malnutrition: ≤5 years old: Mean upper arm circumference (MUAC) \\\u003C115mm\u002F 6-10 years old: MUAC \\\u003C135mm\u002F 11-17 years old: MUAC \\\u003C160mm\u002F ≥ 18 years old: Body mass index (BMI) \\\u003C16kg\u002Fm²\n* (History of) ECG abnormalities: Clinically significant cardiac arrythmias: e.g. 2nd degree or 3rd degree AV block without pacemaker, sustained ventricular tachycardia\u002F Prolonged QTc interval \\>450ms\n* Lab abnormalities: Haemoglobin \\\u003C5.0g\u002FdL\u002F Platelets \\\u003C50 x 10\\^9\u002FL\u002F White blood count \\\u003C1 x 10\\^9\u002FL \u002F Alanine aminotransferase (AST) \u002F aspartate aminotransferase (ALT) \\>3x upper limit of normal (ULN)\u002F Serum creatinine \\>1.5 x ULN\u002F Bilirubin \\>1.5 x ULN\u002F Fasting blood glucose (preferred) \\>7mmol\u002FL (126mg\u002Fdl) or blood glucose \\>11.1 mmol\u002FL (200mg\u002Fdl) at any time\u002F Potassium \\\u003C3.5mmol\u002FL\n* Having received any allopathic treatment for CL lesion(s) in the past 6 months: cryotherapy, thermotherapy, SSG, meglumine antimoniate, paromomycin, pentamidine, liposomal amphotericin B, non-liposomal amphotericin B, miltefosine\n* Diffuse cutaneous leishmaniasis (DCL)\n* Patients on treatment with any of the prohibited medications, which are any treatments with the potential to influence lesion healing, skin condition, or participant safety. This includes any form of chemotherapy, antituberculosis medication, systemic antibiotics or antifungals, antivirals, corticosteroids and immunosuppressants. Topical antibiotics or antifungals are allowed as long as they are not applied on any of the CL lesions.\n* Onset of lesions \\>24 months ago\n* Known allergies or serious adverse reactions to one of the study components\u002Fmedications\n* Any other condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the patient or prevent, limit or confound protocol-specified assessments","4 Years","65 Years",{"count":181,"type":18},900,[76],"MAMS4CL comprises a clinical trial with three embedded sub-studies designed to comprehensively evaluate the administered treatments and assess the impact of CL treatment on patients and the healthcare system.\n\nThe multi-centre multi-arm multi-stage phase 3 clinical trial is designed to rigorously evaluate a total of 4 alternative treatment options for systemic CL against Sodium Stibugluconate (SSG) as the standard of care. The trial comprises two seamlessly linked stages. In stage 1, all four investigational arms will be evaluated against the control arm for efficacy to inform the selection of the arms, based on a pre-defined efficacy threshold that will advance to stage 2, in addition to the control arm. After stage 2, the experimental interventions will be compared with SSG similar to a standard superiority trial for efficacy. The general study design in stage 1 and stage 2 will be identical; only the number of investigational arms may differ.\n\nPatients will be randomized into the respective treatment arms at the recruitment sites of Arba Minch hospital, Boru Meda hospital and ALERT hospital in Ethiopia. Individuals will be hospitalized during the entire course of their treatment. As different arms have different treatment duration, patient hospitalization period and visit schedules will differ between arms. In total, the study will last 180 days for each participant.",[185],"Cutaneous Leihmaniasis",[187,188,189,190,191,192,193,194,195],"Multi-Arm Multi-Stage","Standard of care","Sodium stibogluconate","Miltefosine","Paromomycin","Liposomal amphotericin B","Pentamidine","Ethiopia","cutaneous Leishmaniasis","2026-03-06",{"date":198,"type":28},"2026-03-10",{"date":200,"type":18},"2027-01-01",{"date":202,"type":18},"2029-08-31",{"name":34,"class":35},3,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":15,"minAge":44,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":48,"phases":216,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100627952","phase-3-boostability-assessment-of-three-rabies-pre-exposure-regimens-in-healthy-volunteers-5-years-following-priming-100627952","NCT07455318","Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.","A Multicentre, Open-label Trial in Healthy Volunteers to Assess the Boostability of Three Different Rabies Pre-exposure Prophylaxis Regimens When Administering a Single-dose, Intramuscular Vaccination as Simulated Post-exposure Prophylaxis at Least Five Years Following Priming.","BAZOOKA_221","Inclusion Criteria:\n\n1. ≥ 18 to ≤ 60 years of age at time of inclusion\n2. Willingness to provide written informed consent\n3. Having received PrEP with a 21IM, 2²ID or 1²ID regimen at least 5 years before starting the study. For 21IM and 2²ID interval of 5 days to 56 days between the 2 visits is allowed.\n\nExclusion Criteria:\n\n1. Known allergy to one of the components of the vaccine.\n2. Subjects, who received immunomodulating therapy within the last 3 months (12 weeks).\n\n   Note: See Section 6.3 for detailed guidance on immunomodulating therapies.\n3. Planned vaccination with any inactivated vaccine within 2 weeks before or after vaccination in the study or with any live attenuated vaccine within 1 month before or after each vaccination in the study.\n4. Ongoing pregnancy or active child wish at the time of booster vaccination (D0).\n5. Any other PrEP rabies vaccine schedule\u002Fvaccination than mentioned in the inclusion criteria.\n6. Previous rabies (s)PEP\n7. Inability or unwillingness to comply with study procedures, including protocol-defined visits, assessments, or interventions.","60 Years",{"count":215,"type":18},561,[76],"A multicentre, open label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens (2 x 1IM regimen, 2 x 2 ID regimen, 1 x 2 ID regimen) when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming.",[219],"Rabies (Healthy Volunteers)",[221,222,223,224,225,226],"Rabies","Vaccination regimens","rabies pre-exposure prophylaxis","boostability","prophylaxis","vaccination","2026-03-02",{"date":196,"type":28},{"date":230,"type":18},"2026-05-15",{"date":232,"type":18},"2027-06",{"name":34,"class":35},6,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":43,"sex":15,"minAge":44,"maxAge":4,"enrollmentInfo":243,"targetDuration":72,"studyType":19,"phases":4,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":254,"leadSponsor":256,"locationsCount":63},"100619300","prospective-follow-up-after-mva-bn-booster-vaccination-100619300","NCT07342829","Prospective Follow-up After MVA-BN Booster Vaccination","Prospective On-site Study for the Immunological Follow-up of Individuals Who Received Booster Vaccination With MVA-BN Against Mpox","POQS-Boosted","Inclusion Criteria:\n\n1. Is scheduled to receive a booster dose of MVA-BN\n2. ≥18 years\n3. Willingness to provide written informed consent\n4. Willingness to follow the study schedule\n\nExclusion Criteria:\n\n1\\. Past or current MPXV infection",{"count":244,"type":18},95,"POQS-Boosted is a prospective observational study during which individuals who received Booster vaccination against mpox with the MVA-BN vaccine will be invited to provide biological samples at multiple times over the course of two years.",[247],"Monkeypox (Mpox)",[159,160,226,249],"booster","2026-01-15",{"date":252,"type":28},"2026-01-20",{"date":250,"type":18},{"date":255,"type":18},"2028-06-30",{"name":34,"class":35},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":43,"sex":15,"minAge":265,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":268,"conditions":269,"keywords":273,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":286,"locationsCount":63},"100619489","clinical-aspects-management-and-surveillance-of-febrile-illnesses-in-drc-100619489","NCT07345286","Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC","Aspects Cliniques, Prise en Charge et Surveillance Des Maladies fébriles en RDC","FI-CARE","Inclusion Criteria:\n\n* Ongoing fever objectified at presentation, or documented at home or other health center within 24 hours prior to presentation, defined as: axillary or tympanic temperature \\> 37.5°C, or oral or rectal temperature \\> 38°C.\n* Opportunity for contact between patient (or designated relative) and study team on days 7, 14 and 21.\n* Informed consent to participate signed by the patient (adult) or a legally acceptable representative (child or patients whose condition does not allow them to sign informed consent), with the assent of children aged 12 and over, wherever possible.\n\nExclusion Criteria:\n\n* Child less than two months old.\n* Hospitalization of \\> 48h in the last 14 days.","2 Months",{"count":267,"type":18},500,"The epidemiology and outcome of febrile illnesses in the Democratic Republic of Congo (DRC) is poorly documented. The FIKI² study, a prospective observational study of community-acquired febrile illnesses coordinated by ITM and INRB and conducted at 2 clinical sites from 2021 to 2023, has deepened the knowledge of clinical presentation, etiology, outcome and profile of inflammatory\u002Finfectious biomarkers (white blood cells and C-reactive protein, or CRP).\n\nThe management of febrile illnesses remains fraught with clinical challenges. Overuse of antibiotics in primary care remains a reality in the field, and has been observed in several studies, including FIKI². A number of initiatives are underway to address this problem, such as the use of biomarkers, the development of treatment guidelines and electronic decision support systems. The FIKI² study highlighted the potential role of CRP in rationalizing antibiotic use. In parallel, the 'AWARE antibiotic book' was published at the end of 2022 by the WHO, providing recommendations on the choice (or otherwise) of antibiotic therapy for over 30 common clinical infections, in both primary care and hospital settings.\n\nBased on the results of the FIKI² study, the main aim of the FI-CARE study is to investigate the impact of these new tools (CRP biomarker, AWARE antibiotic book, and electronic decision support systems) on first-line antibiotic use. Secondly, the study will consolidate previous results from FIKI² sites in terms of monitoring the etiologies of community-acquired febrile illnesses (particularly arboviruses); and reinforce this monitoring at new sites (depending on opportunities). This complementary study will also pursue FIKI²'s strategic objectives of strengthening clinical research capacity and consolidating biobanks in the DRC.\n\nFI-CARE is a prospective, observational, multicenter cohort study of adults and children presenting to the emergency department or outpatient clinic with community-acquired febrile illness. A laboratory component with sample storage in a biobank is added in a modular fashion according to laboratory and research capacities, epidemiological interest and available funds.",[270,271,272],"Febrile Illness Acute","Biomarkers","Surveillance",[274,275,276,277,278,279,280],"febrile illness","CRP","biomarkers","surveillance","clinical characteristics","Subsaharan Africa","malaria","2026-01-09",{"date":250,"type":28},{"date":284,"type":28},"2025-01-20",{"date":200,"type":18},{"name":34,"class":35},{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":43,"sex":15,"minAge":44,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":48,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":63},"100591516","implementation-and-evaluation-of-vector-control-methods-in-kinshasa-the-case-of-aedes-100591516","NCT06981442","Implementation and Evaluation of Vector Control Methods in Kinshasa: The Case of Aedes","Implementation and Evaluation of Vector Control Methods in Kinshasa: The Case of Aedes, Vectors of Arboviruses.","At household level:\n\nInclusion Criteria:\n\n* Belong to a household in one of the 4 health areas selected as study arms\n* From 18 years of age to consent for household enrollment and participation in the serosurvey\n* Consenting\n\nExclusion Criteria:\n\n* Not belong to a household in one of the 4 health areas selected as study arms\n* Under 18 years of age\n* Non-consenting\n\nAt health facility level:\n\nInclusion Criteria:\n\n* From 18 years of age\n* Resident of the health zone of Mont Ngafula 1\n* Consenting\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Not resident in the health zone of Mont Ngafula 1\n* Seriously ill and hospitalized, requiring transfusion, presence of blood clotting disorders, allergies resulting from injections, adverse events associated with previous blood sampling, pregnancy\n* Non-consenting",{"count":295,"type":18},2050,[50],"Arboviral diseases are viral diseases transmitted by mosquitoes of the Aedes genus and are constantly spreading throughout the world, constituting a significant threat to public health.\n\nIn Africa, there is very little data on the epidemiological situation of Aedes-borne diseases and programs for monitoring these diseases are very limited. In the Democratic Republic of the Congo (DRC), several epidemics of yellow fever, dengue fever, chikungunya and Zika cases have been reported. In particular, in Kinshasa, the dengue and chikungunya viruses have previously been detected in patients with undifferentiated fevers and several studies have shown entomological transmission indices above the criteria and standards of the World Health Organization (WHO).\n\nThe aim of our study is to implement and evaluate different strategies to control Aedes mosquitoes at different stages of their life cycle in the city of Kinshasa.\n\nIn particular, a before-and-after interventional study will be piloted and tested in the health zone of Kinshasa, with the aim of providing preliminary evidence of the impact of vector control tools.\n\nInterventions will be implemented in 400 households for each arm for 12 months. Before, after and during the interventions, entomological surveys will be conducted in 160 households in each arm to define the density of the vectors. Mosquitoes will be tested for the possible presence of arbovirus RNA (dengue, chikungunya, Zika, yellow fever). During the pre-intervention period, a serological survey for the same diseases transmitted by the Aedes mosquito will be conducted on a sample of 450 people included in two health centers of reference for the health zone of Mont Ngafula 1. A questionnaire will also be administered before and after the intervention implementation to assess the community's knowledge, attitudes and practices towards Aedes mosquito vector control and Aedes-borne diseases.\n\nThe integration of the data collected within the scope of this study will provide an assessment of the feasibility and impact of the tested methods on entomological indicators, as well as determining the exposure and knowledge of Aedes-borne diseases in the Mont Ngafula 1 area.",[299],"Aedes-borne Diseases",[301,302,303],"Vector control","Aedes mosquitoes","Democratic Republic of the Congo","2025-05-12",{"date":306,"type":28},"2025-05-20",{"date":308,"type":28},"2025-03-26",{"date":310,"type":18},"2026-12-31",{"name":34,"class":35},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":320,"targetDuration":322,"studyType":19,"phases":4,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},"100580712","epidemiological-and-pathophysiological-insights-through-a-cross-sectional-survey-epic-100580712","NCT06840860","Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)","Monkeypox Biology, Outcome, Transmission and Epidemiology (MBOTE) Study: Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)","MBOTE-EPIC","Inclusion Criteria:\n\n* Apply to be tested for VMPX at HGR or another test center.\n* Patients of all ages and sexes. However, minors under the age of 12 are excluded from questions on sex life.\n* The patient or his\u002Fher culturally acceptable representative is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria:\n\n* NA",{"count":321,"type":18},1000,"10 Days","This study aims to better understand how mpox is spreading in the DRC, how it affects different groups of people, and how well vaccines protect against it. The study is designed as a cross-sectional survey, meaning researchers will collect and analyze data from patients diagnosed with mpox at a single point in time. It will also use a case-control approach, comparing people who test positive for the virus to those who test negative, to identify risk factors and evaluate the effectiveness of the vaccine.",[247],[157,326,327,328,329,330],"Poxviridae Infections","Democratic Republic of Congo","Infections","Virus Diseases","DNA Virus Infections","2025-04-29",{"date":333,"type":28},"2025-05-02",{"date":335,"type":28},"2025-03-28",{"date":337,"type":18},"2027-02-28",{"name":34,"class":35},2,{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":48,"phases":350,"briefSummary":351,"conditions":352,"keywords":357,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":63},"100382503","phase-3-novel-triple-dose-tuberculosis-retreatment-regimen-100382503","NCT04260477","Novel Triple-dose Tuberculosis Retreatment Regimen","Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger","Tri-Do-Re","Inclusion Criteria:\n\n* All newly registered patients with smear-positive recurrent pulmonary TB\n* Adults as well as children (no age limit)\n* Able and willing to provide written informed consent\n* Added for stage 2: lives within 5 km of a health facility with a medical doctor\n\nExclusion Criteria:\n\n* All patients with TB initially resistant to rifampicin on Xpert MTB\u002FRIF testing\n* Patients transferred to a health facility not supported by the Damien Foundation\n* Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period\n* Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening\n* Pregnant or breastfeeding woman\n* HIV co-infected patients requiring treatment with a protease inhibitor",{"count":349,"type":18},370,[76],"To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).",[353,354,355,356],"Multidrug-resistant Tuberculosis","Pulmonary Tuberculosis","Tuberculosis","Resistance to Tuberculostatic Drugs",[358,355,359,360,361,362],"rifampicin-susceptible-TB","first-line","TB relapse","TB treatment failure","high dose retreatment","2025-04-10",{"date":365,"type":28},"2025-04-13",{"date":367,"type":28},"2021-03-01",{"date":369,"type":18},"2025-09",{"name":34,"class":35},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":43,"sex":15,"minAge":44,"maxAge":45,"enrollmentInfo":379,"targetDuration":4,"studyType":48,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":339},"100525829","phase-3-safety-and-immunogenicity-of-ervebo-and-zabdeno-booster-vaccines-against-ebola-virus-following-previous-vaccination-with-the-zabdenomvabea-or-ervebo-vaccine-schedules-in-drc-100525829","NCT06126822","Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno\u002FMvabea® or Ervebo® Vaccine Schedules in DRC","Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno\u002FMvabea® or Ervebo® Vaccine Schedules in DRC: a Mix-and-match Phase II RCT","EBO-BOOST","Inclusion Criteria:\n\n* Subjects who received either the Ervebo® vaccine (MSD), or the full Zabdeno, Mvabea® vaccine regimen (J\\&J) more than 4 months prior to recruitment\n* Subjects between 18 and 50 years of age at time of randomization\n* Subject must be willing and able to provide informed consent\n* The subject must be in possession of an identification card (or other identification document)\n* Agreement to refrain from blood donation and other vaccinations 30 days after booster vaccination\n* Agreement to share and discuss participant's medical history, medical records and concomitant medications when relevant\n\nExclusion Criteria:\n\n* Participants who previously experienced active Ebola Virus Disease (EVD)\n* Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment\n* Receipt of an additional booster dose of either Ervebo®, Zabdeno®, or any experimental Ebola vaccine\n* Incorrect or incomplete primary vaccination scheme with the Zabdeno, Mvabea® (J\\&J) vaccine\n* Administration of immunoglobulins and\u002For any blood products within three months prior to recruitment.\n* Fever (\\>38°C) within last 24 hours prior to recruitment.\n* Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer and HIV); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months, except topical or short-term oral steroids.\n* Severe and\u002For uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild\u002Fmoderate well controlled comorbidities are allowed)\n* History of anaphylaxis, allergic disease or reactions to any component of the study vaccines\n* History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture\n* History of any thrombotic disorder, thrombocytopenia, thrombotic thrombocytopenia syndrome (TTP), or heparin-induced thrombocytopenia and thrombosis (HITT)\n* Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data\n* Suspected or known alcohol or drug dependency\n* Subject is not readily available by telephone, email or physical address\n\nThe non-vaccinated control group will also adhere to all the above in- and exclusion criteria, with exemption of:\n\n* Agreement to refrain from blood donation and other vaccinations 30 days after study vaccination\n* Subjects who received either the Ervebo® vaccine, or the full Zabdeno, Mvabea® vaccine regimen more than 4 months prior to recruitment\n\nThe latter is rather introduced as an additional exclusion criteria:\n\n* Subjects who received either the Ervebo® vaccine or the full Zabdeno, Mvabea® vaccine regimen",{"count":380,"type":18},624,[76],"The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno\u002FMvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules.\n\nParticipants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations.",[384],"Ebola Virus Disease",[386],"Ebola vaccines","2025-03-13",{"date":389,"type":28},"2025-03-18",{"date":391,"type":28},"2025-02-25",{"date":393,"type":18},"2026-10",{"name":34,"class":35},{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":15,"minAge":178,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":48,"phases":404,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":339},"100569507","phase-3-antimicrobial-adjuvants-to-revert-the-imbalance-of-skin-microbiota-for-improved-outcomes-of-complicated-cutaneous-leishmaniasis-treatment-in-ethiopia-100569507","NCT06695143","Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia","AIM-CL","Clinically suspected complicated CL patients visiting the study site meeting the following inclusion criteria and none of the exclusion criteria:\n\nInclusion:\n\n* Clinical diagnosis of CL\n* Need for systemic treatment (1 or more of these criteria)\n\n  * Mucosal involvement of lesion or at risk for mucosal involvement (\\\u003C 1 cm from the nose, eyes and vermillion border of the lips)\n  * Lesion size \\>4 cm\n  * \\>4 lesions\n  * Lesions on joints or fingers\n  * Lesions previously not responding to local treatment\n  * Lesions unsuitable for local treatment (e.g., eyelids)\n  * Lesions with signs of dissemination (satellite lesions, nodular lymphangitis, sporotrichoid pattern)\n* Age \\> 4 (minimum age to receive systemic treatment with SSG)\n* At least one lesion eligible for treatment\\* (meeting all criteria below)\n\n  * lesion with surface change, including ulcerated, crusted and scaly lesions\n  * distinguishable from other lesions (minimum 0.5 cm apart)\n  * no mucosal involvement against which a topical agent would likely not be effective (e.g., lesions that are located too deep within the nasal passages or on the inner lip, where proper application is challenging and the ointment may be easily removed or not adequately absorbed)\n* Willing and able to provide informed consent. For participants under the age of 18, parental or caregiver consent is required. Additionally, assent must be obtained from adolescents aged 12 to 17\n* Willing to be hospitalized for 4 weeks\n\nExclusion:\n\n* DCL patients\n* Only lesions not eligible for treatment\\*\n* Currently on treatment or having received non-traditional antileishmanial treatment (cryotherapy, thermotherapy, sodium stibogluconate, meglumine antimoniate, paromomycin, pentamidine, AmBisome, miltefosine, non-liposomal amphotericin B) in the past 1 month\n* Currently on or having received topical antibiotic treatment for CL lesion(s) in the past 1 month\n* Currently on or having received systemic antibiotic treatment in general in the past 1 month\n* Currently in need for systemic antibiotics\n* Pregnant (positive pregnancy test at D0) or breastfeeding\n* Abnormal lab values\n\n  * Hemoglobin \\\u003C 5.0g\u002F100mL\n  * Platelets \\\u003C 50 x 10\\^9\u002FL\n  * White blood count \\\u003C 1 x 10\\^9\u002FL\n  * ASAT\u002FALAT \\> 3x upper normal range\n  * Creatinine above the normal limit\n* Prolonged QTc interval or arrythmia on ECG or history of arrythmias\n* Known serious kidney or liver disease\n* Known allergies to one of the study components\u002Fmedications\n* Serious adverse reaction to a previous SSG dose \\*If a patient has multiple lesions, of which some are eligible for treatment and others are not, the patient can still be involved in the study. Only the eligible lesions will be subjected to treatment and outcome assessment.",{"count":403,"type":18},180,[76],"This clinical trial aims to evaluate the effectiveness of combining the standard treatment for complicated cutaneous leishmaniasis (CL), sodium stibogluconate (SSG), with either topical fusidic acid 2% cream or a vehicle cream without active ingredient. The goal is to assess whether this combination improves treatment outcomes by restoring the balance of the skin microbiome (dysbiosis) in patients with severe CL, a condition common in Ethiopia.\n\nThe study will compare three treatment groups:\n\n* Fusidic Acid Group: SSG plus topical fusidic acid for 2 weeks.\n* Vehicle Cream Group: SSG plus topical vehicle cream for 2 weeks.\n* Control Group: SSG only, with no topical treatment.\n\nThe primary objective is to determine if the addition of fusidic acid improves treatment outcomes compared to SSG alone, as measured by substantial improvement in the index lesion at the end of treatment (EoT).\n\nA total of 180 patients will be enrolled at two hospitals in Ethiopia. The trial will run for 24 months, with a focus on understanding how restoring the skin microbiome can improve CL treatment outcomes and potentially provide a low-cost, accessible treatment strategy for CL patients.",[407],"Leishmaniasis, Cutaneous",[409,410],"Cutaneous Leishmania","Complicated cutaneous leishmania","2024-11-16",{"date":413,"type":28},"2024-11-19",{"date":415,"type":18},"2025-04",{"date":417,"type":18},"2027-04",{"name":34,"class":35},{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":15,"minAge":72,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":63},"100555628","optimizing-miltefosine-treatment-for-cutaneous-leishmaniasis-patients-100555628","NCT06514560","OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients","OPTIMILEISH","Inclusion Criteria:\n\n* Clinical or parasitological (microscopy or PCR) confirmation of leishmaniasis\n* Age \\>2\n* Clinical decision to start miltefosine treatment as systemic treatment\n* In case of females of child-bearing age: willing to take contraceptive for 6 months (parenteral or IUD or implant)\n* Willing and able to provide informed consent\n* Willing to be hospitalized for the duration of treatment\n\nExclusion Criteria:\n\n* Currently on treatment or having received modern treatment for leishmaniasis in the last 3 months\n* Pregnant (pregnancy test at D0) or breastfeeding\n* Unlikely to come for follow-up visits\n* Abnormal lab values Hemoglobin \\\u003C5.0g\u002F100mL Platelets \\\u003C50 x 10\\^9\u002FL White blood count \\\u003C1 x 10\\^9\u002FL ASAT\u002FALAT \\>3x upper normal range Creatinine above the normal limit",{"count":427,"type":18},80,"While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking. In this study, longitudinal measurements of parasite and drug concentrations during treatment are done to monitor parasite kinetics as well as pharmacokinetics. This data will be crucial to provide more information on duration and dosing of miltefosine in CL patients globally, and in Ethiopia and pediatric patients in particular.",[430],"Cutaneous Leishmaniases","2024-07-16",{"date":433,"type":28},"2024-07-23",{"date":435,"type":28},"2024-06-18",{"date":437,"type":18},"2026-12-30",{"name":34,"class":35},{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":15,"minAge":447,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":450,"conditions":451,"keywords":452,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":63},"100485556","clinical-prognostic-score-to-predict-relapse-in-vl-100485556","NCT05602610","Clinical Prognostic Score to Predict Relapse in VL","Comprehensive Clinical and Laboratory Assessment of Visceral Leishmaniasis to Develop Clinical Prognostic Tools to Predict Relapse: a Prospective Cohort Study in Ethiopia","CPS","Inclusion Criteria:\n\n* clinically or parasitologically confirmed VL\n\nExclusion Criteria:\n\n* Age under 12 years\n* VL patients already on treatment for 3 days or more\n* Severe critical condition or other circumstances that make the study medically inadvisable\n* Unlikely to adhere to follow up visits during the study period (e.g. patients who live or work very far away) AND not reachable by phone for follow-up information\n* Pregnant or lactating woman","12 Years",{"count":449,"type":18},741,"This prospective cohort study has the aim to develop a prognostic tool to predict relapse in patients suffering from visceral leishmaniasis (VL) from VL endemic regions in Ethiopia.\n\nTherefore, comprehensive clinical and laboratory characterization of all confirmed VL patients before and during treatment will be performed in order to identify the factors that determine prognosis of the patients. This approach would result in more efficient patient care and would reduce the case fatality and morbidity, and improve follow-up and care for those at risk of VL relapse.",[132],[453,454,455,456,194],"leishmaniasis","visceral","neglected","relapse","2024-03-04",{"date":459,"type":28},"2024-03-05",{"date":461,"type":28},"2023-02-03",{"date":463,"type":18},"2027-06-30",{"name":34,"class":35},""]