[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633934":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":54,"centralContacts":59,"locations":71,"responsibleParty":109,"collaborators":41,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":41,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":41,"enrollmentInfo":120,"targetDuration":41,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":131,"whyStopped":41,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Walter Reed Army Institute of Research (WRAIR)","FED",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"TQ+CQ Arm","ACTIVE_COMPARATOR","TQ 300 mg once + Chloroquine (CQ), weight-based dosing for 3 days course",[13,14],"Drug: Tafenoquine (TQ)","Drug: Chloroquine (CQ)",{"label":16,"type":10,"description":17,"interventionNames":18},"TQ+DHA-PPQ Arm","TQ 300 mg once + Dihydroartemisinin-piperaquine (DHA-PPQ), weight-based dosing for 3 days course",[13,19],"Drug: Dihydroartemisinin-piperaquine (DHA-PPQ)",{"label":21,"type":10,"description":22,"interventionNames":23},"TQ+AL Arm","TQ 300 mg once + Artemether-Lumefantrine (AL), weight-based dosing twice daily for the 3-day course",[13,24],"Drug: Artemether-lumefantrine (AL)",{"label":26,"type":10,"description":27,"interventionNames":28},"DHA-PPQ + delayed TQ Arm","DHA-PPQ weight-based dosing for the 3-day course, then pause the treatment for one day and tafenoquine 300 mg once on the 4th day.",[13,19],[30,37,42,48],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Tafenoquine (TQ)","Tafenoquine 150 mg",[26,21,9,16],[36],"KRINTAFEL",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Chloroquine (CQ)","Chloroquine 150 mg base",[9],null,{"type":31,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Dihydroartemisinin-piperaquine (DHA-PPQ)","It is 40 mg DHA\u002F320 mg PPQ",[26,16],[47],"Eurartesim",{"type":31,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Artemether-lumefantrine (AL)","It is 20 mg of artemether and 120 mg lumefantrine",[21],[53],"Coartem",[55],{"name":56,"affiliation":57,"role":58},"Brian Vesely, PhD","Walter Reed Army Institute of Research-Armed Forces Research Institute of Medical Sciences (WRAIR-AFRIMS), Thailand","STUDY_CHAIR",[60,66],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Dr. Krisada Jongsakul, MD","CONTACT","+66 2 696 2700","4607","krisadaj.ca@afrims.org",{"name":67,"role":62,"phone":68,"phoneExt":69,"email":70},"Sidhartha Chaudhury, PhD","+66-2-696-2700","4501","sidhartha.chaudhury.mil@afrims.org,",[72],{"facility":73,"status":41,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Tha Song Yang Hospital","Ratchathewi","Bangkok","10400","Thailand","TH",{"type":80,"coordinates":81},"Point",[82,83],100.53358,13.759,{"lat":83,"lon":82},[86,90,94,97,100,102,104,106,108],{"name":87,"role":62,"phone":88,"phoneExt":41,"email":89},"Tawatchai Yingtaweesak, MD","+66 55 589 255","t_yingtaweesak@hotmail.com",{"name":91,"role":62,"phone":92,"phoneExt":41,"email":93},"Chanasorn Srichan, MD","+66 81 065872","chanasorn42@gmail.com",{"name":95,"role":96,"phone":41,"phoneExt":41,"email":41},"Krisada Jongsakul, MD","PRINCIPAL_INVESTIGATOR",{"name":98,"role":99,"phone":41,"phoneExt":41,"email":41},"Eric Garges, MD","SUB_INVESTIGATOR",{"name":101,"role":99,"phone":41,"phoneExt":41,"email":41},"Krit Harncharoenkul, MD",{"name":103,"role":99,"phone":41,"phoneExt":41,"email":41},"Michele Spring, MD",{"name":105,"role":99,"phone":41,"phoneExt":41,"email":41},"Edgie-Mark Co, MD",{"name":107,"role":99,"phone":41,"phoneExt":41,"email":41},"Panupong Kowsurat, MD",{"name":91,"role":99,"phone":41,"phoneExt":41,"email":41},{"type":110,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100633934","tafenoquine-combinations-for-improved-radical-cure-efficacy-of-plasmodium-vivax-100633934",false,"NCT07533136","Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax","Evaluating Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax","Inclusion Criteria:\n\n* Participants who meet all of the following criteria may participate in the study:\n\n  * Thai or non-Thai, male or non-pregnant\u002Fnon-lactating female, aged at least 18 years\n  * Willingness to participate in the study and provides signed written informed consent form\n  * Have P. vivax malaria mono-infection as determined by blood smear, with a parasitemia range of 100-400,000 parasites\u002Fmicroliter\n  * Have normal (non-deficient or \\>70% activity) G6PD phenotype as measured by quantitative spectrophotometry\n  * Agree to not seek outside medical care prior to contacting the WRAIR-AFRIMS study team if a fever develops during study participation (approximately 180 days), unless emergency medical care is required\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded from this study:\n\n  * Have an allergic reaction to any of the study drugs or components (AL,TQ, artemisinins, PPQ or CQ)\n  * History of anti-malarial drug use within the past 14 days (28 days for mefloquine or PPQ)\n  * On screening EKG, found to have a QTcF of greater than 450 milliseconds (ms) (470 ms for females)\n  * History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias\n  * Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, neurologic, or renal functional abnormality, as determined by history, physical examination, and laboratory evaluation; specific tests for this criteria, and in the definition of severe malaria, include:\n\n    * Hemoglobin level of \\\u003C7 g\u002FdL\n    * Alanine aminotransferase (ALT\u002FSGPT) and\u002For Aspartate transaminase (AST\u002FSGOT) more than two times upper limit of normal or total bilirubin greater than 3 mg\u002FdL\n    * Serum creatinine greater than 3 mg\u002FdL\n  * History of or current psychotic disorders (schizophrenia or other type of psychosis with hallucinations\u002Fdelusions)\n  * Have symptoms of severe malaria needing urgent treatment, such as impaired consciousness, shock, seizures, respiratory distress, unable to eat or drink, prostration (WHO guidelines for malaria, 2024) or other signs\u002Fsymptoms of concern to the doctors\n  * Are a pregnant or lactating female, or female of childbearing age, up to 50 years of age or otherwise individually assessed for childbearing potential, who does not agree to use an acceptable form of contraception (e.g. pills or injectable) during this study and for 1 month after study completion\n  * Chronic use of medications that may cause drug interactions with tafenoquine (metformin) and\u002For drugs known to prolong the QTc interval.\n  * Any other significant finding that in the opinion of the study physician would increase the risk of having an adverse outcome from participating in this study","ALL","18 Years",{"count":121,"type":122},300,"ESTIMATED","INTERVENTIONAL",[125],"NA","This study is to conduct a clinical trial of tafenoquine combinations to compare the rates of therapeutic efficacy of dihydroartemisinin-piperaquine or artemether-lumefantrine with tafenoquine to chloroquine plus tafenoquine in preventing recurrence of Plasmodium vivax over a 6-month period in adult subjects with uncomplicated P. vivax infection living in Thailand.",[128],"Uncomplicated P. Vivax Mono-infection",[130],"Plasmodium vivax, Tafenoquine, Artemisinin combination therapy","NOT_YET_RECRUITING","2026-04-09",{"date":134,"type":135},"2026-04-16","ACTUAL",{"date":137,"type":122},"2026-05-01",{"date":139,"type":122},"2029-05-30",{"name":5,"class":6},1]