[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628966":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":32,"overallOfficials":13,"centralContacts":13,"locations":42,"responsibleParty":107,"collaborators":109,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":13,"eligibilityCriteria":129,"healthyVolunteers":126,"sex":130,"minAge":131,"maxAge":13,"enrollmentInfo":132,"targetDuration":13,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":45,"whyStopped":13,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Menzies School of Health Research","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and efficacy of high dose primaquine","1. To assess the safety and efficacy of high dose primaquine (1mg\u002Fkg per day over 7 days) among patients with intermediate (30-70%) G6PD activity.\n2. To assess the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (\\\u003C30% activity)","6 Months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21,27],{"label":22,"type":23,"description":24,"interventionNames":25},"Participants with G6PD intermediate status receive another active regimen appropriate for intermedia","ACTIVE_COMPARATOR","G6PD activity 30-\\\u003C70%",[26],"Drug: Patients with G6PD enzyme activities between 30 and \u003C70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg\u002Fkg\u002Fday for 7 days",{"label":28,"type":23,"description":29,"interventionNames":30},"Participants withG6PD deficient status receive a specific treatment regimen appropriate for deficie","G6PD activity ≤30%",[31],"Drug: Patients with G6PD enzyme activities \u003C30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg\u002Fkg dose).",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":13},"DRUG","Patients with G6PD enzyme activities between 30 and \u003C70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg\u002Fkg\u002Fday for 7 days","Primaquine 1mg\u002Fkg\u002Fday for 7 days",[22],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"Patients with G6PD enzyme activities \u003C30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg\u002Fkg dose).","8 weekly Primaquine (0.75mg\u002Fkg dose).",[28],[43,61,77,93],{"facility":44,"status":45,"city":46,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Dr Marcus Lacerda","RECRUITING","Manaus","Brazil","BR",{"type":50,"coordinates":51},"Point",[52,53],-60.025,-3.10194,{"lat":53,"lon":52},[56],{"name":57,"role":58,"phone":59,"phoneExt":13,"email":60},"Aretha Omena","CONTACT","+55984208810","aretha.omena@gmail.com",{"facility":62,"status":63,"city":64,"state":13,"zip":13,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Arba Minch General Hospital","NOT_YET_RECRUITING","Arba Minch","Ethiopia","ET",{"type":50,"coordinates":68},[69,70],37.55,6.03333,{"lat":70,"lon":69},[73],{"name":74,"role":58,"phone":75,"phoneExt":13,"email":76},"Tamiru Shibiru Degaga, MD","+251911704767","tamiru.shibiru@menzies.edu.au",{"facility":78,"status":45,"city":79,"state":80,"zip":13,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Dr Moses Laman and Dr Brioni Moore","Alexishafen","Madang Province","Papua New Guinea","PG",{"type":50,"coordinates":84},[85,86],145.80288,-5.09074,{"lat":86,"lon":85},[89],{"name":90,"role":58,"phone":91,"phoneExt":13,"email":92},"Dr Paula Tesine Doctor, Medical Doctor","+67570755875","paula.tesine@pngimr.org.pg",{"facility":94,"status":45,"city":95,"state":96,"zip":13,"country":81,"countryCode":82,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Papua New Guinea Institute of Medical Research","Port Moresby","Magang",{"type":50,"coordinates":98},[99,100],147.15089,-9.47723,{"lat":100,"lon":99},[103],{"name":104,"role":58,"phone":105,"phoneExt":13,"email":106},"DR Moses Laman","+6754340208","moses.laman@pngimr.org.pg",{"type":108,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[110,112,114,116,118,120,122],{"name":111,"class":6},"Curtin University",{"name":113,"class":6},"University of Melbourne",{"name":115,"class":6},"Arba Minch University",{"name":94,"class":117},"OTHER_GOV",{"name":119,"class":6},"Mahidol Oxford Tropical Medicine Research Unit",{"name":121,"class":6},"Oxford University Clinical Research Unit, Vietnam",{"name":123,"class":6},"Indonesia University","100628966","phase-4-primaquine-for-vivax-malaria-in-g6pd-intermediate-and-deficient-cases-100628966",false,"NCT07468513","Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.","Inclusion Criteria:\n\n* • P. vivax peripheral parasitaemia (mono-infection)\n\n  * G6PD intermediate or deficient status (G6PD activity 30-\\\u003C70% or ≤30% 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  * Age ≥18 years\n  * Haemoglobin at presentation ≥8g\u002Fdl\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\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":133,"type":134},100,"ESTIMATED","INTERVENTIONAL",[137],"PHASE4","A non randomized observation study that is aiming to assess the safety and efficacy of high dose primaquine (1mg\u002Fkg per day over 7 days) among patients with intermediate (30-70%) G6PD activity and the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (\\\u003C30% activity)",[140,141],"Vivax Malaria","G6PD Deficiency",[143,144],"Primaquine in G6PD deficiency","Vivax malaria in G6PD deficient patients","2026-03-09",{"date":147,"type":148},"2026-03-12","ACTUAL",{"date":150,"type":148},"2024-05-17",{"date":152,"type":134},"2028-12-31",{"name":5,"class":6},4]