[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628967":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":42,"studyPopulation":42,"armGroups":54,"interventions":67,"overallOfficials":77,"centralContacts":81,"locations":90,"responsibleParty":176,"collaborators":178,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":195,"sex":201,"minAge":202,"maxAge":42,"enrollmentInfo":203,"targetDuration":42,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":214,"whyStopped":42,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},{"fullName":5,"class":6},"Menzies School of Health Research","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence risk of any recurrent vivax parasitaemia within 4 months.","The incidence risk (time to first event) of any recurrent P. vivax parasitaemia within 4 months as determined by microscopy","4 Months",[14,18,22,25,28,31,35,39],{"measure":15,"description":16,"timeFrame":17},"The incidence risk of any P. vivax parasitaemia within 6 months.","The incidence risk (time to first event) of any P. vivax parasitaemia within 6 months as determined by microscopy","6 months",{"measure":19,"description":20,"timeFrame":21},"Incidence of haemoglobin drop >25% to \u003C7g\u002Fdl within 14 days of treatment.","Number of participants experiencing a haemoglobin decrease of \\>25% from baseline resulting in Hb\\\u003C7g\u002Fdl","0-14 days",{"measure":23,"description":24,"timeFrame":21},"Incidence of moderate anaemia within 14 days after starting primaquine","Number of participants developing haemoglobin \\>=5g\u002Fdl and \\\u003C7g\u002Fdl within 14 days after treatment initiation",{"measure":26,"description":27,"timeFrame":21},"Incidence of severe anaemia within 14 days after starting Primaquine","Number of participants developing haemoglobin \\\u003C5g\u002Fdl within 14 days of treatment initiation.",{"measure":29,"description":30,"timeFrame":17},"• The proportion of patients requiring blood transfusion within the 6 months follow up period.","Participants requiring transfusion due to haemolysis or severe anaemia",{"measure":32,"description":33,"timeFrame":34},"The incidence risk of symptomatic P. vivax parasitaemia within 4 months.","The incidence risk (time to first event) of symptomatic P. vivax parasitaemia within 4 months as determined by microscopy.","4 months",{"measure":36,"description":37,"timeFrame":38},"Proportion of adverse events within 14 days.","The number and proportion of adverse events within 14 days after start of treatment","14 days",{"measure":40,"description":40,"timeFrame":41},"The number and proportion of serious adverse events.","6 Months",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":42,"timePerspective":42,"maskingInfo":48},"RANDOMIZED","PARALLEL","Health care facility based, randomised, controlled, double blinded, trial with 2 arms","TREATMENT",{"masking":49,"maskingDescription":42,"whoMasked":50},"TRIPLE",[51,52,53],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[55,62],{"label":56,"type":57,"description":58,"interventionNames":59},"High-dose Short-course Primaquine (PQ7)","ACTIVE_COMPARATOR","Participants in this arm will receive a high-dose, short-course primaquine regimen (PQ7), consisting of a total dose of 7 mg\u002Fkg administered as 1 mg\u002Fkg once daily in the morning for 7 days (Day 0-6). A matching placebo will be given in the evening on the first three days (Day 0-2).",[60,61],"Drug: High dose ultra short Primaquine","Other: Placebo",{"label":63,"type":64,"description":65,"interventionNames":66},"High dose ultra- short course Primaquine (PQ 3.5)","EXPERIMENTAL","Participants in this arm will receive a high-dose, ultra-short primaquine regimen (PQ3.5), consisting of a total dose of 7 mg\u002Fkg administered as 1 mg\u002Fkg twice daily for 3.5 days (Day 0-2 morning and evening doses, and Day 3 morning dose). A matching placebo will be given as the morning dose on Days 4-6.",[60,61],[68,73],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":42},"DRUG","High dose ultra short Primaquine","High-dose, ultra-short primaquine (PQ3.5): 7mg\u002Fkg total dose given as 1mg\u002Fkg twice daily over 3.5 days (day 0, 1 and 2 morning and evening doses, and day 3 morning dose) followed by placebo as morning doses on day 4, 5 and 6.",[63,56],{"type":6,"name":74,"description":75,"armGroupLabels":76,"otherNames":42},"Placebo","Matching placebo administered according to the arm schedule. Morning dose on Days 4-6 for PQ3.5 arm and Evening dose on the first 3 days for PQ 7 arm).",[63,56],[78],{"name":79,"affiliation":5,"role":80},"Kamala Thriemer, Professor","PRINCIPAL_INVESTIGATOR",[82,86],{"name":79,"role":83,"phone":84,"phoneExt":42,"email":85},"CONTACT","+61889468644","Kamala.Ley-Thriemer@menzies.edu.au",{"name":87,"role":83,"phone":88,"phoneExt":42,"email":89},"Hellen Mnjala, MSc","+61889468675","hellen.mnjala@menzies.edu.au",[91,108,122,140,158],{"facility":92,"status":42,"city":93,"state":93,"zip":42,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Arba Minch University","Arba Minch","Ethiopia","ET",{"type":97,"coordinates":98},"Point",[99,100],37.55,6.03333,{"lat":100,"lon":99},[103,107],{"name":104,"role":83,"phone":105,"phoneExt":42,"email":106},"Dr Tamiru Degaga","+252911704767","drtamshib1@gmail.com",{"name":104,"role":80,"phone":42,"phoneExt":42,"email":42},{"facility":109,"status":42,"city":110,"state":110,"zip":42,"country":94,"countryCode":95,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Jimma University","Jimma",{"type":97,"coordinates":112},[113,114],36.83441,7.67344,{"lat":114,"lon":113},[117,121],{"name":118,"role":83,"phone":119,"phoneExt":42,"email":120},"Dr Daniel Yilma","+251471111458","danielyilmab@gmail.com",{"name":118,"role":80,"phone":42,"phoneExt":42,"email":42},{"facility":123,"status":42,"city":124,"state":125,"zip":42,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Universitas Sumatera","Bandar Lampung","Lampung","Indonesia","ID",{"type":97,"coordinates":129},[130,131],105.26111,-5.42917,{"lat":131,"lon":130},[134,138],{"name":135,"role":83,"phone":136,"phoneExt":42,"email":137},"Dr Ayodhia Pitaloka Pasaribu, Professor","+628126024392","ayodhia@usu.ac.id",{"name":139,"role":80,"phone":42,"phoneExt":42,"email":42},"Dr Ayodhia Pitaloka Pasaribu",{"facility":141,"status":42,"city":142,"state":143,"zip":42,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Aga Khan University, Karachi","Karachi","Thatta","Pakistan","PK",{"type":97,"coordinates":147},[148,149],67.0104,24.8608,{"lat":149,"lon":148},[152,156],{"name":153,"role":83,"phone":154,"phoneExt":42,"email":155},"Dr Asim Beg, Professor","+923002028490","masim.beg@aku.edu",{"name":157,"role":80,"phone":42,"phoneExt":42,"email":42},"Dr Asim Beg",{"facility":159,"status":42,"city":160,"state":161,"zip":42,"country":162,"countryCode":163,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Papua New Guinea Institute of Medical Research","Port Moresby","Magang","Papua New Guinea","PG",{"type":97,"coordinates":165},[166,167],147.15089,-9.47723,{"lat":167,"lon":166},[170,174],{"name":171,"role":83,"phone":172,"phoneExt":42,"email":173},"DR Moses Laman","+6754340208","moses.laman@pngimr.org.pg",{"name":175,"role":80,"phone":42,"phoneExt":42,"email":42},"Dr Moses Laman",{"type":177,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[179,181,183,185,186,187,189,191],{"name":180,"class":6},"Curtin University",{"name":182,"class":6},"University of Melbourne",{"name":159,"class":184},"OTHER_GOV",{"name":92,"class":6},{"name":109,"class":6},{"name":188,"class":6},"Universitas Sumatera Utara",{"name":190,"class":6},"Aga Khan University",{"name":192,"class":184},"PathWest Laboratory Medicine WA","100628967","phase-3-an-ultra-short-course-of-primaquine-for-the-radical-cure-of-vivax-malaria-100628967",false,"NCT07468526","An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria","An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria (PRIMUS)","PRIMUS","Inclusion Criteria:\n\n* P. vivax peripheral parasitaemia as determined by microscopy\n* G6PD normal status (G6PD activity ≥70% of the site specific adjusted male median as determined by the Standard G6PD (SD Bioline, ROK))\n* Fever (temperature ≥37.5°C) or history of fever in the preceding 48 hours,\n* Age ≥5 years\n* Bodyweight ≥14kg\n* Living in the study area and willing to be followed-up for six months\n\nExclusion Criteria:\n\n* Signs or symptoms of severe malaria,\n* Anaemia (defined as Hb \\\u003C8g\u002Fdl) and measured by the Standard G6PD\n* Pregnant or lactating\n* Blood transfusion within the preceding four months\n* Regular or recent use (last month) of tafenoquine, primaquine or dapsone\n* Known hypersensitivity to any of the study drugs","ALL","5 Years",{"count":204,"type":205},1019,"ESTIMATED","INTERVENTIONAL",[208],"PHASE3","Current treatment regimens to prevent relapsing malaria are too long. A shorter higher dose treatment could improve treatment outcomes, but this needs to be balanced against increased risk of side effects. Recent data from a trial in children in Papua New Guinea (PNG) suggests a shortened treatment of 3 days is safe and effective. Our multicentre trial will assess the safety and efficacy of an ultra-short primaquine course. This trial is expected to directly influence global treatment policies.",[211],"Malaria",[213,199],"An ultra-short course of primaquine for the radical cure of vivax malaria","NOT_YET_RECRUITING","2026-03-09",{"date":217,"type":218},"2026-03-12","ACTUAL",{"date":220,"type":205},"2026-06-01",{"date":222,"type":205},"2028-04-01",{"name":5,"class":6},5]