[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356647":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":34,"locations":46,"responsibleParty":133,"collaborators":135,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":34,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":166,"whyStopped":34,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"University of Oxford","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Artemether-lumefantrine+amodiaquine (AL+AQ)","EXPERIMENTAL","Triple ACTs",[13],"Drug: Artemether-lumefantrine+ Amodiaquine (AL+AQ)",{"label":15,"type":16,"description":17,"interventionNames":18},"artemether-lumefantrine+placebo (AL+PBO)","ACTIVE_COMPARATOR","ACTs",[19],"Drug: Artemether-lumefantrine + placebo (AL+PBO)",{"label":21,"type":10,"description":11,"interventionNames":22},"Artesunate-mefloquine+Piperaquine (AS-MQ+PPQ)",[23],"Drug: Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)",{"label":25,"type":16,"description":17,"interventionNames":26},"Artesunate-mefloquine+placebo (AS-MQ+PBO)",[27],"Drug: Artesunate-mefloquine+placebo (AS-MQ+PBO)",[29,35,39,43],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Artemether-lumefantrine+ Amodiaquine (AL+AQ)","AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children.\n\nThe dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg\u002Fkg and lumefantrine 29-144 mg\u002Fkg over 3 days.\n\nAQ: is available as dispersible tablets of 40 mg. The weight-based treatment schedule aims for a dosage of approximately 10mg (4.5-15mg)\u002Fkg\u002Fday amodiaquine for three days.",[9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Artemether-lumefantrine + placebo (AL+PBO)","AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children.\n\nThe dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg\u002Fkg and lumefantrine 29-144 mg\u002Fkg over 3 days.\n\nPBO: Placebo tablets for amodiaquine are identical in size, shape and color to the amodiaquine tablets.",[15],{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)","AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg\u002Fkg\u002Fday.\n\nMQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg\u002Fkg\u002Fday.\n\nPPQ: Piperaquine will be administered according to an optimised dosing schedule using tablets of 160 or 500 mg of piperaquine tetraphosphate. The weight-based treatment aims for a dosage of approximately.\n\n* 24 mg\u002Fkg\u002Fday in patients \\\u003C25 kg (range 16.0 - 32.0 mg\u002Fkg) piperaquine for three days, thereby approaching the WHO-recommended target range of 20 - 32 mg\u002Fkg per day.\n* 18 mg\u002Fkg\u002Fday in patients ≥25 kg (range 15.0 - 29.4 mg\u002Fkg) piperaquine for three days, thereby approaching the WHO-recommended target range of 16 - 27 mg\u002Fkg per day.",[21],{"type":30,"name":25,"description":44,"armGroupLabels":45,"otherNames":34},"AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg\u002Fkg\u002Fday.\n\nMQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg\u002Fkg\u002Fday.\n\nPBO: Placebo tablets for piperaquine are identical in size, shape and colour to the piperaquine tablets.",[25],[47,58,69,80,92,103,113,122],{"facility":48,"status":34,"city":49,"state":34,"zip":34,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":34},"Institut des Sciences et Techniques (INSTech)","Bobo-Dioulasso","Burkina Faso","BF",{"type":53,"coordinates":54},"Point",[55,56],-4.29489,11.18064,{"lat":56,"lon":55},{"facility":59,"status":34,"city":60,"state":34,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":34},"Kinshasa School of Public Health","Kinshasa","BP 11850 Kin","Democratic Republic of the Congo","CD",{"type":53,"coordinates":65},[66,67],15.31357,-4.32758,{"lat":67,"lon":66},{"facility":70,"status":34,"city":71,"state":34,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":34},"Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah","Conakry","B.P. 2649","Guinea","GN",{"type":53,"coordinates":76},[77,78],-13.67729,9.53795,{"lat":78,"lon":77},{"facility":81,"status":34,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":34},"Centre for Malaria and Other Tropical Diseases (CEMTROD)","Ilorin","Kwara State","1459","Nigeria","NG",{"type":53,"coordinates":88},[89,90],4.54214,8.49664,{"lat":90,"lon":89},{"facility":93,"status":34,"city":94,"state":34,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":34},"Epicentre Niger","Niamey","BP: 13 330","Niger","NE",{"type":53,"coordinates":99},[100,101],2.1098,13.51366,{"lat":101,"lon":100},{"facility":104,"status":34,"city":105,"state":34,"zip":34,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":34},"College of Medicine and Health Sciences, University of Rwanda","Kigali","Rwanda","RW",{"type":53,"coordinates":109},[110,111],30.05885,-1.94995,{"lat":111,"lon":110},{"facility":114,"status":34,"city":115,"state":34,"zip":34,"country":116,"countryCode":34,"cosmosGeoPoint":117,"geoPoint":121,"contacts":34},"National Institute For Medical Research (NIMR), Tanga Medical Research Centre","Tanga","Tanzania",{"type":53,"coordinates":118},[119,120],39.09875,-5.06893,{"lat":120,"lon":119},{"facility":123,"status":34,"city":124,"state":125,"zip":126,"country":127,"countryCode":34,"cosmosGeoPoint":128,"geoPoint":132,"contacts":34},"MRC Unit The Gambia at LSHTM","Fajara","City of Banjul","273","The Gambia",{"type":53,"coordinates":129},[130,131],-16.69639,13.47,{"lat":131,"lon":130},{"type":134,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[136],{"name":137,"class":6},"Mahidol Oxford Tropical Medicine Research Unit","100356647","phase-3-a-trial-to-compare-the-efficacy-safety-and-tolerability-of-combinations-of-3-anti-malarial-drugs-against-combina-tions-of-2-anti-malarial-drugs-100356647",false,"NCT03923725","A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.","A Multi-centre Randomised Controlled Non-inferiority Trial to Compare the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies Versus First-line ACTs + Placebo for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Africa","DeTACT-Africa","Inclusion Criteria:\n\n* Male or female, aged ≥6 months to \\\u003C12 years (For Gambia, Rwanda sites only: ≥6 months)\n* Ability to take oral medication\n* Acute uncomplicated P. falciparum monoinfection\n* Asexual P. falciparum parasitaemia: 1,000\u002FµL to ≤10% parasitaemia, determined on a peripheral blood film (At Gambia, Rwanda sites only: For subjects ≥12 years - 1000\u002FµL to 200,000\u002FµL)\n* Fever defined as ≥ 37.5°C tympanic temperature or a history of fever within the last 24 hours\n* Written informed consent by the subject or by parent\u002Fguardian in case of children lower than the age of consent and assent if required (per local regulations)\n* Willingness and ability of the subjects or parents\u002Fguardians to comply with the study protocol for the duration of the study\n\nExclusion Criteria:\n\n* Signs of severe malaria (adapted from WHO criteria)\n* Patients not fulfilling criteria for severe malaria but with another indication for parenteral antimalarial treatment at the discretion of the treating physician\n* Haematocrit \\\u003C15% at screening (For Gambia, Rwanda sites only: For subjects ≥12 years - Haematocrit \\\u003C20% at screening)\n* Subjects who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days OR mefloquine or piperaquine within the previous 30 days\n* In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 14 days.\n* Acute illness other than malaria requiring systemic treatment\n* Severe acute malnutrition (in Niger only - only those patients with Severe Acute Malnutrition and complications requiring inpatient nutritional treatment will be excluded)\n* Known HIV infection\n* Known tuberculosis infection\n* For females: post-menarche (For Gambia, Rwanda sites only: females who are pregnant, trying to get pregnant or are lactating)\n* History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy\n* Previous splenectomy\n* Enrolment in DeTACT in the previous 3 months\n* Participation in another interventional study in the previous 3 months","ALL","6 Months","12 Years",{"count":150,"type":151},2583,"ACTUAL","INTERVENTIONAL",[154],"PHASE3","A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.",[157],"Plasmodium Falciparum Malaria (Uncomplicated)",[159,160,161,162,163,164,165],"Artemether","Lumefantrine","Amodiaquine","Artesunate","Piperaquine","Mefloquine","Triple Artemisinin-based Combination Therapy (TACT)","COMPLETED","2025-11-14",{"date":169,"type":151},"2025-11-18",{"date":171,"type":151},"2020-09-01",{"date":173,"type":151},"2024-03-15",{"name":5,"class":6},8]