[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Epicentre\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":172},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,59,88,119,143],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100595929","phase-4-comparison-of-two-strategies-for-administering-the-r21-matrix-m-vaccine-in-a-context-of-seasonal-malaria-transmission-in-chad-100595929",false,"NCT07038837","Comparison of Two Strategies for Administering the R21-Matrix M Vaccine in a Context of Seasonal Malaria Transmission in Chad","Cluster Randomised Non-inferiority Trial Comparing Malaria Incidence When Implementing R21\u002FMatrix-M Synchronized With Seasonal Malaria Chemoprevention Distribution Versus R21\u002FMatrix-M Given Routinely Through the EPI in Two Health Districts in Chad (CoSAV-R21)","COSAV-R21","Inclusion Criteria:\n\n* • Routine arm\n\n  1. Aged 6 to 11 months at the time of the first R21\u002FMM vaccination (dose 1).\n  2. Residing in a village participating in the study and randomized to the routine arm.\n  3. Oral consent provided by the child's parent\u002Fguardian.\n\n     * Synchronised arm\n\n  \u003C!-- -->\n\n  1. Aged 6 to 59 months at the time of the first R21\u002FMM vaccination (dose 1) during the first 3 rounds of SMC (2025).\n  2. Residing in a village participating in the study and randomized to the synchronized arm.\n  3. Oral consent provided by the child's parent\u002Fguardian.\n\nExclusion Criteria:\n\n* Exclusion criteria for both arms according to Chad national EPI guidelines\n\nMalaria vaccine is not recommended for children with known severe hypersensitivity:\n\n* To a previous dose of a malaria vaccine\n* To a previous dose of hepatitis B vaccine\n* One of the components of the R21\u002FMM vaccine\n\nMild illness - including respiratory tract infections, mild diarrhoea and fever below 38.5° C - is not a contraindication to R21\u002FMM vaccination. Malnutrition and being HIV-seropositive are also not contraindications to R21\u002FMM vaccination.",true,"ALL","6 Months","59 Months",{"count":22,"type":23},70000,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","This is a two-arm, cluster-randomised, phase IV trial conducted in Chad to assess the protective efficacy and impact in real-life conditions of a new strategy for administering the R21\u002FMM malaria vaccine, synchronized within a seasonal malaria chemoprevention (SMC) campaign, among children living in areas of high seasonal malaria transmission.\n\nIn this study, a cluster is defined as the catchment area of a primary care health centre. In Chad, each catchment area is known as a 'zone of responsibility' (French: Zone de Responsibilité' \\[ZR\\]).\n\nTwenty-six (26) of the total 27 ZRs in the districts of Moïssala and Dembo will be randomized in a 1:1 ratio to receive a 4-dose (3 primary doses + 1 booster) R21\u002FMM schedule either (1) integrated into the routine EPI vaccination program (the \"Routine\" control arm), or (2) synchronized with an annual seasonal malaria chemoprevention (SMC) campaign (the \"Synchronized\" intervention arm).\n\nMalaria incidence: R21\u002FMM effectiveness will be assessed using the incidence of biologically confirmed clinical malaria (trial primary endpoint). The incidence of clinical malaria will be determined through enhanced surveillance of malaria cases in health centres and hospitals over a 17-month period (August 2025 - December 2026).\n\nCoverage surveys: Cross-sectional surveys (cluster sampling) will be carried out to measure R21\u002FMM vaccine coverage, SMC coverage, coverage of other malaria prevention measures, and coverage of other EPI vaccines.\n\nNested case-control study: A sub-sample of children admitted to Moïssala District Hospital with severe clinical malaria will be offered the opportunity to participate in a nested case-control study designed to estimate the individual protective efficacy of R21\u002FMM against severe malaria.\n\nAditionnaly, the INTEGREVAC ancillary study's objective is to evaluate the cost-effectiveness, acceptability and feasibility of the synchronised vaccination strategy in the context of the ongoing COSAV-R21 trial, to inform policy decisions for the effective deployment of malaria vaccines in SMC implementation areas.\n\nMethodology and planned work:\n\n(i) A qualitative study using in-depth interviews (IDIs) and group discussions with key stakeholders at the national, health facility, and community levels, including caregivers of children eligible for vaccination, in Chad, at several points during the trial. We will explore stakeholders' and beneficiaries' perceptions and experiences of the synchronised SMC vaccination strategy (trial intervention arm) compared to age-based vaccine administration under the routine immunisation programme (trial control arm), as well as considerations for implementing these strategies. Interviews with healthcare providers, including those administering R21 and SMC, and community members will assess the feasibility of implementing the integrated vaccination strategy via SMC.\n\n(ii) An economic evaluation including a cost-effectiveness analysis and a nested equity analysis will be conducted. The economic evaluation will include a cost analysis to carefully identify and measure the additional costs associated with adding malaria vaccination to the EPI delivery platform and, separately, to the SMC delivery channel. Analysis of key cost drivers will enable us to identify potential efficiency savings, provide evidence for country funding requests (e.g., to GAVI and the Global Fund) and for the malaria vaccine strategy budgeting\u002Fplanning process. Cost-effectiveness and equity analyses of each vaccine delivery strategy will provide evidence to help national programmes plan future malaria vaccine delivery and inform global guidance and on methods of delivering these vaccines, while providing valuable evidence on the real-world cost-effectiveness of malaria vaccination.\n\n(iii) Impact modelling will estimate the costs, impact, and cost-effectiveness of scaling up the intervention approach to the whole of Chad, under different temporal and spatial scenarios.",[29,30],"Malaria Infection","Malaria Vaccines",[32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Vaccine","Malaria","Implementation strategy","Children","Pediatric","synchronized","coverage","prevention","incidence","prevalence","qualitative","mixed methods","cost effectiveness","Seasonal Malaria Chemoprevention","RECRUITING","2026-04-10",{"date":49,"type":50},"2026-04-15","ACTUAL",{"date":52,"type":50},"2025-06-16",{"date":54,"type":23},"2028-06",{"name":56,"class":57},"Epicentre","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":17,"sex":18,"minAge":66,"maxAge":20,"enrollmentInfo":67,"targetDuration":4,"studyType":24,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100582197","phase-4-integrating-malaria-vaccine-with-seasonal-malaria-chemoprevention-in-west-africa-100582197","NCT06860178","Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa","IMVACS","Inclusion criteria:\n\nControl arms :\n\n* Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination;\n* Resident in the catchment area of a health centre assigned to the control arm;\n* Willingness to comply with the study procedures;\n* Written informed consent from Parent\u002FGuardian.\n\nIntervention arms :\n\n* Children aged 3-59 months at the time of first study vaccination;\n* Resident in the catchment area of a health centre assigned to the intervention arm;\n* Willingness to comply with the study procedures;\n* Written informed consent from Parent\u002FGuardian.\n\nExclusion Criteria:\n\n1. History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;\n2. Any history of anaphylaxis in relation to vaccination;\n3. Known chronic illness;\n4. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial;\n5. History of vaccination with another malaria vaccine. -","3 Months",{"count":68,"type":23},40000,[26],"This is a multi-site, multi-disciplinary, Phase-4 two-arm cluster-randomised non-inferiority trial in Burkina Faso and Mali to evaluate the effectiveness and real-life impact of a novel integrated delivery strategy of the R21 malaria vaccine alongside SMC among children in areas with highly seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a health centre. Clusters will be randomised to receive either year-round age-based routine EPI vaccination for children aged 5-36 months (\"Routine EPI Vaccination\") in Burkina Faso or an annual campaign of the 3-dose primary series in children aged 5-36 months prior to the malaria season and SMC delivery (''Routine Pre-SMC vaccination'') in Mali versus an annual campaign of the 3-dose primary series aligned with SMC distribution in children aged 3-59 months (\"Integrated SMC Vaccination\") in each country. Effectiveness will be assessed in terms of clinical malaria, vaccine coverage, acceptability, feasibility, and cost-effectiveness.\n\nMalaria incidence will be determined using routine surveillance activities for clinical malaria detection and reporting in each country. Cross-sectional surveys will be conducted to determine the prevalence of parasitaemia in the communities. In addition, the acceptability, feasibility, coverage and cost-effectiveness of the different delivery systems of R21\u002FMatrix-M will be assessed.",[72],"Malaria Vaccine",[74,75,76,77,78],"malaria","CPS","pediatric","vaccine","R21","2025-08-05",{"date":81,"type":50},"2025-08-08",{"date":83,"type":50},"2025-06-10",{"date":85,"type":23},"2027-12",{"name":56,"class":57},2,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":18,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":99,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":58},"100571067","high-flow-nasal-oxygen-therapy-an-implementation-study-in-pediatric-wards-100571067","NCT06715423","High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards","HFNO","Inclusion Criteria:\n\n* prescription of HFNO by clinician\n* parent consenting to the use of the data","1 Month","5 Years",{"count":98,"type":23},960,"2 Weeks","OBSERVATIONAL","The purpose of this study is to prospectively evaluate the process of implementing HFNO in several MSF projects, varying according to geographical and programmatic contexts, population, health structures, human resources, and management. It will generate evidence on the operational feasibility (in terms of human resources, equipment, logistics and costs) of integrating HFNO into PICU standard of care, as well as on the users' and caregivers' perspectives on HFNO and on the children clinical outcomes observed where HFNO is implemented. This relevant information will guide MSF in the decision making of scaling up HFNO therapy in its projects.",[103,104],"Moderate Respiratory Distress","Severe Respiratory Distress",[106,107,108,109],"oxygen","high flow","pneumonia","pediatrics","NOT_YET_RECRUITING","2025-01-28",{"date":113,"type":50},"2025-01-30",{"date":115,"type":23},"2025-01",{"date":117,"type":23},"2025-12",{"name":56,"class":57},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":58},"100427989","impact-study-of-cholera-vaccination-in-endemic-areas---clinical-surveillance-100427989","NCT04853186","Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance","Cholera Control in Endemic Regions of Africa: Clinical Surveillance and Cholera Shedding Study in the Context of Mass Vaccination Campaigns, Democratic Republic of the Congo","For Surveillance in study CTCs\n\nInclusion Criteria:\n\n* All patients presenting at the time of the study to any selected Cholera Treatment Center\u002FCholera Treatment Unit (CTC\u002FCTU), matching the case definition and giving his\u002Fher consent (or assent for children 8 to 17 years old) to participate in the study will be eligible.\n\nExclusion Criteria:\n\n* Patients who decline to participate will be excluded from the study.\n\nFollow up of individuals with active cholera shedding:\n\nInclusion Criteria:\n\n1. present to any selected CTC\u002FCTU, match the case definition, participate to the clinical surveillance activity and test positive to RDT OR\n2. Be a household member of a person respecting inclusion criteria 1. AND for whom the head of the household has provided verbal consent to participate AND giving his\u002Fher consent (or assent for children 8 to 17 years old) to participate in the study will be eligible.\n\nExclusion Criteria:\n\n\\- Individuals who decline to participate will be excluded from the study, as well as households for whom the head of the household (and his or her representative) decline the participation of his\u002Fher household.",{"count":127,"type":23},6000,"This project aims to fill this essential knowledge gap by assessing the impact of oral cholera vaccine mass campaigns in 2 sites (urban and rural) in DRC, described in this protocol. The evidence generated from this project will be key to develop future strategies regarding cholera vaccine use in endemic settings, including places with higher burden in terms of cholera mortality.",[130],"Cholera",[132,133,134],"Cholera incidence rates","Mass vaccination campaign","V.Cholerae","2024-09-11",{"date":137,"type":50},"2024-09-19",{"date":139,"type":50},"2021-05-11",{"date":141,"type":23},"2026-12-31",{"name":56,"class":57},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":24,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":58},"100545511","effectiveness-of-a-microbiome-directed-food-to-promote-programmatic-and-sustained-nutritional-recovery-among-children-with-uncomplicated-acute-malnutrition-100545511","NCT06382857","Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition","Inclusion Criteria:\n\n* for children with Severe Acute Malnutrition (SAM): MUAC \\\u003C 115 mm and\u002For WLZ \\\u003C -3 and\u002For mild (+) or moderate (++) edema\n* for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC \\\u003C 125 mm and\u002For -3 ≤ WHZ \\\u003C -2\n* Caregiver providing informed consent\n\nExclusion Criteria:\n\n* Medical complications requiring inpatient treatment, as identified by the national protocol\n* Not eating\u002Flack of appetite (as informed by appetite test and investigator judgement)\n* Re-admission into the program within 2 months of previous default\n* for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)\n* for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)\n* Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection\n* Known contraindication\u002F hypersensitivity\u002Fallergy to study interventions (chickpea\u002Fsoy flour, banana, peanut)\n* Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community","23 Months",{"count":151,"type":23},7356,[153],"NA","This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \\\u003C 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.",[156],"Malnutrition, Child",[158,159,160,161,162,163],"Malnutrition","SAM","MAM","Child","MDF","Microbiome","2024-08-26",{"date":166,"type":50},"2024-08-27",{"date":168,"type":50},"2024-05-02",{"date":170,"type":23},"2026-02-01",{"name":56,"class":57},""]