[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527517":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":102,"collaborators":104,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":30,"enrollmentInfo":131,"targetDuration":30,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":30,"overallStatus":51,"whyStopped":30,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Menzies School of Health Research","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"TQRevised","EXPERIMENTAL","Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg\u002Fkg)",[13],"Drug: Tafenoquine",{"label":15,"type":16,"description":17,"interventionNames":18},"TQStandard","ACTIVE_COMPARATOR","Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"PQ7","Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg\u002Fkg) over 7 days (PQ7)",[23],"Drug: Primaquine",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Tafenoquine","oral treatment",[9,15],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Primaquine",[20],[35],{"name":36,"affiliation":5,"role":37},"Kamala N Thriemer, PhD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":30,"email":43},"Hellen Mnjala","CONTACT","+610889468675","hellen.mnjala@menzies.edu.au",{"name":45,"role":41,"phone":46,"phoneExt":30,"email":47},"kamala K Thriemer","+610889468644","kamala.ley-thriemer@menzies.edu.au",[49,61,74,92],{"facility":50,"status":51,"city":52,"state":30,"zip":30,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":30},"Dr Marcus Lacerda","RECRUITING","Manaus","Brazil","BR",{"type":56,"coordinates":57},"Point",[58,59],-60.025,-3.10194,{"lat":59,"lon":58},{"facility":62,"status":51,"city":63,"state":30,"zip":30,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Arba Minch General Hospital","Arba Minch","Ethiopia","ET",{"type":56,"coordinates":67},[68,69],37.55,6.03333,{"lat":69,"lon":68},[72],{"name":73,"role":41,"phone":30,"phoneExt":30,"email":30},"Tamiru Shibiru Degaga, MD",{"facility":75,"status":76,"city":77,"state":30,"zip":30,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Puskesmas Hanura","NOT_YET_RECRUITING","Hanura","Indonesia","ID",{"type":56,"coordinates":81},[82,83],107.40222,-6.60861,{"lat":83,"lon":82},[86,90],{"name":87,"role":41,"phone":88,"phoneExt":30,"email":89},"Inge Prof Sutanto","000","sutanto.inge@yahoo.com",{"name":91,"role":41,"phone":30,"phoneExt":30,"email":30},"Erni Dr Juwita",{"facility":93,"status":51,"city":94,"state":30,"zip":30,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":30},"Dr Moses Laman and Dr Brioni Moore","Alexishafen","Papua New Guinea","PG",{"type":56,"coordinates":98},[99,100],145.80288,-5.09074,{"lat":100,"lon":99},{"type":103,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[105,107,109,111,113,116,118],{"name":106,"class":6},"University of Melbourne",{"name":108,"class":6},"Fundação de Medicina Tropical Dr. Heitor Vieira Dourado",{"name":110,"class":6},"Arba Minch University",{"name":112,"class":6},"Addis Ababa University",{"name":114,"class":115},"Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia","UNKNOWN",{"name":117,"class":6},"Curtin University",{"name":119,"class":120},"Papua New Guinea Institute of Medical Research","OTHER_GOV","100527517","phase-3-a-revised-tafenoquine-dose-to-improve-radical-cure-for-vivax-malaria-100527517",false,"NCT06148792","A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria","A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised","TADORE","Inclusion Criteria:\n\n* P. vivax peripheral parasitaemia (mono-infection)\n* G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))\n* Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours\n* Written informed consent\n* Living in the study area and willing to be followed for six months\n\nExclusion Criteria:\n\n* Danger signs or symptoms of severe malaria\n* Anaemia (defined as Hb \\\u003C8g\u002Fdl)\n* Pregnant or lactating females\n* Regular use of drugs with haemolytic potential\n* Known hypersensitivity to any of the study drugs.","ALL","18 Years",{"count":132,"type":133},1090,"ESTIMATED","INTERVENTIONAL",[136],"PHASE3","The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question\\[s\\] it aims to answer are:\n\n* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg\u002Fkg) non-inferior to high dose primaquine (7mg\u002Fkg over 7 days)\n* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg\u002Fkg) superior to fixed dose tafenoquine (300mg)\n* is the tolerability and safety of TQRevised acceptable\n* is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg\u002Fkg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.",[139],"Vivax Malaria","2025-07-15",{"date":142,"type":143},"2025-07-18","ACTUAL",{"date":145,"type":143},"2024-05-10",{"date":147,"type":133},"2027-03-01",{"name":5,"class":6},4]