[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-malaria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-malaria":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,58,89,115,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100564089","phase-4-pdmc-implementation-trial-in-kenya-100564089",false,"NCT06624631","PDMC Implementation Trial in Kenya","Delivery Strategies for Malaria Chemoprevention in the Post-discharge Management of Children Hospitalised With Severe Anaemia or Severe Malaria: Cluster and Individually Randomised Controlled Implementation Trial and Economic Evaluation in Kenya","PDMC-SL","Inclusion Criteria:\n\nCLUSTERS\n\n* Health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria.\n* \\>=40 children per year admitted with severe anaemia or severe malaria\n* Agreement to participate by facility management\n* Located in areas with moderate to high malaria transmission\n\nINDIVIDUAL PARTICIPANTS\n\n* Aged \\\u003C10 years of both sexes\n* Hospitalised with 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\u002For the presence of microscopy or RDT confirmed Plasmodium infection\n\nExclusion Criteria:\n\nCLUSTERS\n\n\\- Health facilities without subservient lower-level health facilities\n\nINDIVIDUAL PARTICIPANTS\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 and cotrimoxazole prophylaxis are not exclusion criteria.","ALL","9 Years",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this implementation trial is to evaluate at least two alternative delivery strategies and adherence support for malaria chemoprevention with dihydroartemisinin-piperaquine in the post-discharge management of children hospitalised with severe anaemia or severe malaria to optimise adherence in Kenya.\n\nThe actual interventions to be evaluated have been co-designed with national stakeholders during an initial formative research stage.",[27,28],"Severe Malaria","Severe Anemia",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Children","Antimalarial","Prevention","Chemoprevention","Caregivers","Patient discharge","Healthcare providers","Health economics","Qualitative research","Feasibility","Cost effectiveness","Kenya","Artemisinins","School age","Pre-school","RECRUITING","2025-11-18",{"date":48,"type":49},"2025-11-21","ACTUAL",{"date":51,"type":49},"2025-09-05",{"date":53,"type":21},"2026-09-30",{"name":55,"class":56},"Liverpool School of Tropical Medicine","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100493924","platelet-directed-whole-blood-transfusion-strategy-for-malaria-100493924","NCT05711485","Platelet-Directed Whole Blood Transfusion Strategy for Malaria","Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]","PLATFORM","Inclusion Criteria:\n\n* Age \\\u003C5 years\n* Platelet count ≤75,000\u002FuL\n* Hemoglobin \\>5 and ≤9 g\u002FdL\n* P. falciparum parasitemia ≥500 parasites\u002FuL\n* Diagnosis of severe malaria meeting World Health Organization (WHO) criteria\n* Ability and willingness of the legal guardian to comply with study protocol for the duration of the study\n* Residence within health clinic catchment area\n* Signed informed consent obtained from the parent or legal guardian of the participant\n\nExclusion Criteria:\n\n* Residence in foster care or children otherwise under government supervision\n* Residence outside the hospital catchment area, or plan to leave the area\n* Presence of any other condition or abnormality which, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data\n* Any contraindication to whole blood transfusion","6 Months","59 Months",{"count":69,"type":21},132,[71],"NA","Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.",[27,74],"Thrombocytopenia",[76,77,78],"Malaria","Plasmodium falciparum","Zambia","2025-10-07",{"date":81,"type":49},"2025-10-09",{"date":83,"type":49},"2024-02-24",{"date":85,"type":21},"2028-05-31",{"name":87,"class":56},"Johns Hopkins Bloomberg School of Public Health",2,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":15,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":88},"100562326","phase-4-post-discharge-malaria-chemoprevention-implementation-trial-in-benin-100562326","NCT06601712","Post-discharge Malaria Chemoprevention Implementation Trial in Benin","Delivery Strategies for Malaria Chemoprevention in the Post-discharge Management of Children Hospitalised With Severe Anaemia or Severe Malaria: a Cluster Randomised Controlled Implementation Trial in Benin","Inclusion Criteria:\n\n* Aged below 10 years of both sexes\n* Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin below 5.0 g\u002Fdl or PCV below 15%, 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\nExclusion Criteria:\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 below 5 kg\n* HIV infection and cotrimoxazole prophylaxis are not exclusion criteria",{"count":97,"type":21},648,[24],"The proposed research aims to conduct implementation trials in Benin, co-designed with national stakeholders, to evaluate different delivery strategies for optimizing health system delivery of post-discharge malaria chemoprevention (PDMC) drugs and adherence to PDMC. This chemoprevention strategy is effective in reducing hospital readmissions and deaths after discharge. However, there is no clear delivery platform for PDMC, and adherence to the 3-day dosing regimen, provided monthly three times after discharge, is a potential limitation. The current trial will provide evidence-based data on acceptability, feasibility, and cost-effectiveness to aid decision-makers. The evidence generated will be used to support the effective implementation and scale-up of PDMC in high malaria-endemic areas such as Benin.",[27,101],"Severe Anaemia",[30,31,32,33,34,35,103,37,38,39,104,105,42,43,44],"Health care providers","Cost-effectiveness","Benin","2025-07-21",{"date":108,"type":49},"2025-07-24",{"date":110,"type":49},"2025-07-02",{"date":112,"type":21},"2026-12-31",{"name":114,"class":56},"Institut de Recherche Clinique du Benin",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":88},"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",{"count":124,"type":21},398,[126],"PHASE3","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",[76,27,101,129],"Post Discharge",[131,132,133,134,135,136,137],"monoclonal antibodies","malaria","post-discharge","prevention","severe anaemia","severe malaria","children","2025-07-14",{"date":108,"type":49},{"date":141,"type":49},"2025-05-02",{"date":143,"type":21},"2027-04",{"name":55,"class":56},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":165,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":57},"100564942","enhancing-pediatric-acute-care-through-adaptive-e-learning-and-in-person-skills-practice-in-tanzania-100564942","NCT06635733","Enhancing Pediatric Acute Care Through Adaptive E-Learning and In-Person Skills Practice in Tanzania","A Cluster Randomized Controlled Trial of the Pediatric Acute Care Education (PACE) Program Combining Adaptive E-Learning with In-Person Skills Practice in Tanzania","PACE","Inclusion Criteria:\n\n* Healthcare providers actively involved in pediatric care at one of the selected healthcare centers.\n* Completion of core Pediatric Acute Care Education (PACE) adaptive learning modules prior to study participation.\n* Willingness to participate in In-Person Skills Practice (ISP) sessions.\n* Ability to engage with either the Rhapsode Capable™ platform (intervention group) or paper-based ISP methods (control group).\n* Minimum proficiency in written and spoken English.\n\nExclusion Criteria:\n\n* Healthcare providers not involved in pediatric or newborn clinical care at the time of recruitment.\n* Providers unable or unwilling to attend ISP sessions facilitated by clinical champions.\n* Individuals with no prior engagement in the PACE program.\n* Providers with significant technological barriers that prevent the use of the Rhapsode Capable™ platform (for the intervention group only).",{"count":154,"type":21},100,[71],"The goal of this clinical trial is to evaluate whether the integration of in-person skills practice (ISP) with an adaptive e-learning platform can improve refresher learning progress (RLP) among healthcare providers in pediatric care settings in Tanzania.\n\nThe main questions it aims to answer are:\n\nCan healthcare providers who participate in ISP sessions facilitated by clinical champions achieve greater improvements in refresher learning progress (RLP)? Will providers in the intervention group demonstrate improved metacognition and practical skill performance compared to those in the control group? Researchers will compare healthcare providers using the ISP digital platform (Rhapsode Capable™) to providers using paper-based ISP to see if the digital platform results in significantly higher RLP and fewer skill-based errors.\n\nParticipants will:\n\nComplete adaptive e-learning modules focused on pediatric care topics (e.g., newborn resuscitation, severe malnutrition).\n\nParticipate in ISP sessions where clinical champions provide feedback and assess performance.",[158,159,27,160,161,162,163,164],"Newborn Resuscitation","Severe Malnutrition","Severe Pneumonia","Severe Dehydration","In-Service Training","Computer-Assisted Instruction","Simulation Training",[166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184],"Pediatric acute care","Newborn resuscitation","Severe malnutrition in children","Severe malaria treatment","Severe dehydration management","Pediatric pneumonia care","In-person skills practice (ISP)","Adaptive e-learning for healthcare providers","Clinical skills training in low-resource settings","Health provider education","Clinical champions","Tanzania healthcare providers","Pediatric emergency training","Blended learning in pediatric care","Refresher learning progress (RLP)","Cluster randomized controlled trial (RCT)","Rhapsode Capable™ platform","Skills assessment in pediatric care","Continuous professional development (CPD) for healthcare providers","NOT_YET_RECRUITING","2024-10-08",{"date":188,"type":49},"2024-10-10",{"date":190,"type":21},"2025-01-06",{"date":192,"type":21},"2026-12-01",{"name":194,"class":56},"Stanford University"]