[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357826":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":34,"locations":47,"responsibleParty":82,"collaborators":84,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":34,"enrollmentInfo":97,"targetDuration":34,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":113,"whyStopped":34,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University of Oxford","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Artemether-lumefantrine+amodiaquine (AL+AQ)","ACTIVE_COMPARATOR","Triple ACTs",[13],"Drug: Artemether-lumefantrine+amodiaquine",{"label":15,"type":10,"description":11,"interventionNames":16},"Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)",[17],"Drug: Artesunate-mefloquine+piperaquine",{"label":19,"type":10,"description":20,"interventionNames":21},"artemether-lumefantrine+placebo (AL+PBO)","ACTs",[22],"Drug: Artemether-lumefantrine+placebo",{"label":24,"type":10,"description":25,"interventionNames":26},"Artesunate-mefloquine+placebo (AS-MQ+PBO)","ACTs.",[27],"Drug: Artesunate-mefloquine+placebo",[29,35,39,43],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Artemether-lumefantrine+amodiaquine","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: Amodiaquine 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: 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.",[19],{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Artesunate-mefloquine+piperaquine","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.",[15],{"type":30,"name":44,"description":45,"armGroupLabels":46,"otherNames":34},"Artesunate-mefloquine+placebo","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.",[24],[48,60,72],{"facility":49,"status":34,"city":50,"state":51,"zip":34,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":34},"Ramu Upazilla Health Complex","Cox’s Bāzār","Chittagong","Bangladesh","BD",{"type":55,"coordinates":56},"Point",[57,58],92.00955,21.43973,{"lat":58,"lon":57},{"facility":61,"status":34,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":34},"Kravanh Referral Hospital","Phnum Kravanh","Pursat","150501","Cambodia","KH",{"type":55,"coordinates":68},[69,70],103.7694,12.35121,{"lat":70,"lon":69},{"facility":73,"status":34,"city":74,"state":75,"zip":76,"country":65,"countryCode":66,"cosmosGeoPoint":77,"geoPoint":81,"contacts":34},"Siem Pang Health Center","Siem Pang","Stung Treng","1803",{"type":55,"coordinates":78},[79,80],106.38838,14.11728,{"lat":80,"lon":79},{"type":83,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[85],{"name":86,"class":6},"Mahidol Oxford Tropical Medicine Research Unit","100357826","phase-3-a-trial-to-compare-the-efficacy-safety-and-tolerability-of-combinations-of-3-anti-malarial-drugs-against-combinations-of-2-anti-malarial-drugs-asia-100357826",false,"NCT03939104","A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia)","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 Asia","DeTACT-ASIA","Inclusion Criteria:\n\n* Male or female, \\>\u002F= 6 months\n* Ability to take oral medication\n* Acute uncomplicated P. falciparum monoinfection\n* Asexual P. falciparum parasitaemia: 96 to 200,000\u002FµL, determined on a peripheral blood film\n* Fever defined as \\>\u002F= 37.5°C tympanic temperature or a history of fever within the last 24 hours\n* Written informed consent by the subject or 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 \\\u003C 20% 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* Acute illness other than malaria requiring systemic treatment\n* Severe acute malnutrition\n* Known HIV infection\n* Known tuberculosis infection\n* For females: 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\n\nCriteria for severe malaria\n\n* Impaired consciousness (Glasgow Coma Scale, Blantyre Coma Scale)\n* Prostration\n* Respiratory distress (defined as maximal respiratory rate, by age)\n* ≥2 convulsions in the past 24 hours\n* Circulatory collapse\n* Pulmonary edema\n* Abnormal bleeding\n* Visible jaundice\n* Haemoglobinuria (blackwater)\n* Hyperparasitaemia (\\>10%)","ALL","6 Months",{"count":98,"type":99},103,"ACTUAL","INTERVENTIONAL",[102],"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 (AS-MQ+PPQ) with the ACTs artemether-lumefantrine + placebo (AL+PBO) and artesunate- mefloquine + placebo (AS-MQ+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.",[105],"Plasmodium Falciparum Malaria (Uncomplicated)",[107,108,109,110,111,112],"Artemether","Lumefantrine","Amodiaquine","Piperaquine","Artesunate","Mefloquine","COMPLETED","2024-03-18",{"date":116,"type":99},"2024-03-20",{"date":118,"type":99},"2021-06-30",{"date":120,"type":99},"2023-01-28",{"name":5,"class":6},3]