[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527517":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":46,"studyPopulation":46,"armGroups":53,"interventions":70,"overallOfficials":79,"centralContacts":83,"locations":93,"responsibleParty":147,"collaborators":149,"id":166,"slug":167,"hasResults":168,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":168,"sex":174,"minAge":175,"maxAge":46,"enrollmentInfo":176,"targetDuration":46,"studyType":179,"phases":180,"briefSummary":182,"conditions":183,"keywords":46,"overallStatus":96,"whyStopped":46,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Menzies School of Health Research","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"The incidence risk of vivax parasitaemia","The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy.\n\n* compared between TQRevised and the PQ7 (non-inferiority)\n* compared between TQRevised and TQStandard (superiority)","4 months",[14,16,19,22,24,27,30,34,38,42],{"measure":10,"description":15,"timeFrame":12},"The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy compared between TQStandard and PQ7",{"measure":17,"description":18,"timeFrame":12},"The incidence risk of symptomatic vivax parasitaemia","The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 4 months follow up period as determined by microscopy",{"measure":10,"description":20,"timeFrame":21},"The incidence risk (time to first event) of any P. vivax parasitaemia at 6-month follow up as determined by microscopy","6 months",{"measure":17,"description":23,"timeFrame":21},"The incidence risk (time to first event) of symptomatic P. vivax parasitaemia at 6-month follow up as determined by microscopy",{"measure":25,"description":26,"timeFrame":21},"The incidence rate of vivax parasitaemia","The incidence rate (events per person-time) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy",{"measure":28,"description":29,"timeFrame":21},"The incidence rate of symptomatic vivax parasitaemia","The incidence rate (events per person-time) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy",{"measure":31,"description":32,"timeFrame":33},"The incidence risk of anaemia","The incidence risk of developing severe anaemia (Hb \\\u003C 5g\u002Fdl) or moderate (5g\u002Fdl and \\\u003C7g\u002Fdl) anaemia within 7 and 14 days of starting treatment and\u002For requiring blood transfusion within the 6 months follow up period","7 and 14 days, 6 months",{"measure":35,"description":36,"timeFrame":37},"The incidence risk of an acute drop in Hb","The incidence risk of an acute drop in Hb of \\>25% to \\\u003C7g\u002Fdl within 7 and 14 days of starting treatment","7 and 14 days",{"measure":39,"description":40,"timeFrame":41},"Adverse events","The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment","42 days",{"measure":43,"description":44,"timeFrame":45},"Meth Hb concentration","day 7 methaemoglobin concentration","day 7",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":52,"maskingDescription":46,"whoMasked":46},"NONE",[54,60,65],{"label":55,"type":56,"description":57,"interventionNames":58},"TQRevised","EXPERIMENTAL","Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg\u002Fkg)",[59],"Drug: Tafenoquine",{"label":61,"type":62,"description":63,"interventionNames":64},"TQStandard","ACTIVE_COMPARATOR","Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)",[59],{"label":66,"type":56,"description":67,"interventionNames":68},"PQ7","Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg\u002Fkg) over 7 days (PQ7)",[69],"Drug: Primaquine",[71,76],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":46},"DRUG","Tafenoquine","oral treatment",[55,61],{"type":72,"name":77,"description":74,"armGroupLabels":78,"otherNames":46},"Primaquine",[66],[80],{"name":81,"affiliation":5,"role":82},"Kamala N Thriemer, PhD","PRINCIPAL_INVESTIGATOR",[84,89],{"name":85,"role":86,"phone":87,"phoneExt":46,"email":88},"Hellen Mnjala","CONTACT","+610889468675","hellen.mnjala@menzies.edu.au",{"name":90,"role":86,"phone":91,"phoneExt":46,"email":92},"kamala K Thriemer","+610889468644","kamala.ley-thriemer@menzies.edu.au",[94,106,119,137],{"facility":95,"status":96,"city":97,"state":46,"zip":46,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":46},"Dr Marcus Lacerda","RECRUITING","Manaus","Brazil","BR",{"type":101,"coordinates":102},"Point",[103,104],-60.025,-3.10194,{"lat":104,"lon":103},{"facility":107,"status":96,"city":108,"state":46,"zip":46,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Arba Minch General Hospital","Arba Minch","Ethiopia","ET",{"type":101,"coordinates":112},[113,114],37.55,6.03333,{"lat":114,"lon":113},[117],{"name":118,"role":86,"phone":46,"phoneExt":46,"email":46},"Tamiru Shibiru Degaga, MD",{"facility":120,"status":121,"city":122,"state":46,"zip":46,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Puskesmas Hanura","NOT_YET_RECRUITING","Hanura","Indonesia","ID",{"type":101,"coordinates":126},[127,128],107.40222,-6.60861,{"lat":128,"lon":127},[131,135],{"name":132,"role":86,"phone":133,"phoneExt":46,"email":134},"Inge Prof Sutanto","000","sutanto.inge@yahoo.com",{"name":136,"role":86,"phone":46,"phoneExt":46,"email":46},"Erni Dr Juwita",{"facility":138,"status":96,"city":139,"state":46,"zip":46,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":146,"contacts":46},"Dr Moses Laman and Dr Brioni Moore","Alexishafen","Papua New Guinea","PG",{"type":101,"coordinates":143},[144,145],145.80288,-5.09074,{"lat":145,"lon":144},{"type":148,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[150,152,154,156,158,161,163],{"name":151,"class":6},"University of Melbourne",{"name":153,"class":6},"Fundação de Medicina Tropical Dr. Heitor Vieira Dourado",{"name":155,"class":6},"Arba Minch University",{"name":157,"class":6},"Addis Ababa University",{"name":159,"class":160},"Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia","UNKNOWN",{"name":162,"class":6},"Curtin University",{"name":164,"class":165},"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":177,"type":178},1090,"ESTIMATED","INTERVENTIONAL",[181],"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.",[184],"Vivax Malaria","2025-07-15",{"date":187,"type":188},"2025-07-18","ACTUAL",{"date":190,"type":188},"2024-05-10",{"date":192,"type":178},"2027-03-01",{"name":5,"class":6},4]