[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657058":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":40,"studyPopulation":31,"armGroups":41,"interventions":49,"overallOfficials":59,"centralContacts":64,"locations":69,"responsibleParty":104,"collaborators":106,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":31,"enrollmentInfo":120,"targetDuration":31,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":139,"whyStopped":31,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University of Oxford","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":31},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Tafenoquine blood concentration-time curve area under the curve from time zero to infinity (AUC[0-∞])","The area under the tafenoquine concentration-time curve from time zero to infinity (AUC\\[0-∞\\]) will be estimated from the concentration-time data.","days 1, 7, 28 and month 4",{"measure":14,"description":15,"timeFrame":12},"Maximum observed tafenoquine blood concentration (Cmax)","Maximum observed blood concentration (Cmax) will be estimated from the concentration-time data.",{"measure":17,"description":18,"timeFrame":12},"Terminal elimination half-life of tafenoquine (t½)","Terminal elimination half-life (t½) will be estimated from the concentration-time data.",[20,24,28],{"measure":21,"description":22,"timeFrame":23},"Number of adverse events and serious adverse events","The number of treatment-emergent adverse events and serious adverse events reported by caregivers, observed by study staff, or identified through clinical assessments will be recorded from treatment initiation through Month 4.","up to month 4",{"measure":25,"description":26,"timeFrame":27},"Methaemoglobin levels measured by oximetry","Methaemoglobin levels will be measured by oximetry on Day 7 to assess the hematologic safety profile of tafenoquine treatment.","day 7",{"measure":29,"description":30,"timeFrame":23},"CYP2D6 genotype and associated phenotype as defined by the Clinical Pharmacogenetics Implementation Consortium (CPIC)","CYP2D6 genotype will be determined and translated into predicted metabolizer phenotype according to Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines to evaluate genetic variation in drug metabolism.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":31,"timePerspective":31,"maskingInfo":37},"NA","SINGLE_GROUP","All enrolled participants with Plasmodium vivax malaria receive the study treatment regimen (tafenoquine with chloroquine) and are followed prospectively to assess safety, efficacy, pharmacokinetics, and recurrence outcomes over 4 months.","TREATMENT",{"masking":38,"maskingDescription":39,"whoMasked":31},"NONE","This is an open-label study. Investigators, study staff, participants, and parents\u002Fguardians are aware of the treatment administered. All drug administrations are directly observed by study staff.","Objectives:\n\nPrimary Objective:\n\n* Characterise the pharmacokinetic profile of tafenoquine in G6PD normal (G6PD activity ≥70%) children ≤12kg and \\>28 days old with P. vivax mono-infection\n\nSecondary Objectives:\n\n* Characterise the safety and tolerability of tafenoquine in children ≤12kg and \\>28 days old\n* Correlate day 7 methaemoglobin levels to the tafenoquine pharmacokinetic profile\n* Correlate the CYP2D6 metaboliser status and genotype with tafenoquine concentrations in vivo\n\nRecruitment\n\nPotential participants will be recruited from the outpatient setting at the following sites:\n\n* Shoklo Malaria Research Unit (SMRU), Thailand\n* Oxford University Clinical Research Unit (OUCRU), Vietnam\n\nThis study recruits P. vivax patients who seek treatment at public or local health facilities. The malaria diagnosis will be performed by designated staff (such as the research team or government health care staff) at each facility. The patients who are diagnosed with P. vivax malaria by blood rapid diagnostic test (RDT) or malaria smear will be invited to participate in the study.\n\nThe trained study staff will explain the following; 1) The nature of the study; 2) The nature of the data collected; 3) Confidentiality and vulnerability; 4) Safety and alternatives; 5) The potential risks involved; 6) The potential benefits to the participants. A properly signed consent form by the parent\u002Fguardian of the patient will be obtained before participation.\n\nFollowing written informed consent from a parent\u002Fguardian, participants will undergo screening with finger-prick haemoglobin and G6PD enzyme activity testing to confirm eligibility. Age-adjusted G6PD activity thresholds, based on 70% of the median activity for children aged 28 days to 4 months, will be applied for participants \\>28 days to 6 months and ≥6 months to 2 years of age. Eligible participants will be enrolled and undergo venous blood collection (3.14 mL on Day 0) using standard sterile venipuncture procedures. Blood samples will be labelled according to study requirements. Total blood volume collected during the study will be approximately 3.76 mL for participants without recurrence.\n\nAll study drug administrations will be directly observed by study staff to ensure adherence. Tafenoquine dosing will be weight-based: \\\u003C5 kg, 25 mg; ≥5 kg to \\\u003C10 kg, 50 mg; and ≥10 kg to 12 kg, 100 mg. Participants will be observed during dosing and compliance monitored throughout the study. If vomiting occurs within 30 minutes of administration, the full dose will be re-administered; if vomiting occurs 31 to 60 minutes after administration, half the dose will be re-administered. At each observed dosing visit, study staff will record adverse events, vital signs, and the date and time of study drug administration, and review available laboratory results before dosing.\n\nAfter enrolment, participants will be admitted for observation and supervised treatment until malaria smears are negative on two consecutive days or schizonticidal treatment is completed (approximately 3 to 7 days). Follow-up visits will occur on Days 7, 14, 21, and 28, and Months 2, 3, and 4. Scheduled assessments include medication and concomitant medication review, adverse event monitoring, vital signs, physical examination, collection of protocol-specified blood and urine samples, and review of laboratory results. Visit windows are ±3 days for Days 7, 14, and 21; +2 weeks\u002F-3 days for Day 28; and ±2 weeks for Months 2, 3, and 4.\n\nAt Month 4, participants with unresolved adverse events will be referred for appropriate clinical follow-up. Participants experiencing Plasmodium vivax recurrence will be treated according to national guidelines and will repeat study assessments from Day 0, excluding complete blood count and biochemistry testing. Additional assessments will include haemoglobin (Hemocue® Hb 301), malaria smear, methaemoglobin, and chloroquine and tafenoquine drug level measurements. Follow-up will then continue according to the Day 0 schedule, without extending the overall study duration.\n\nThe study will end after completion of the last study visit of the last participant.\n\nThis project is funded by the National Institutes of Health (NIH), award number U01AI195203.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"Tafenoquine Plus Chloroquine","EXPERIMENTAL","Participants with Plasmodium vivax malaria will receive oral chloroquine and tafenoquine under direct observation. Chloroquine tablets (250 mg) will be administered at a total dose of 25 mg\u002Fkg base divided over 3 days (Days 0, 1, and 2) as schizonticidal treatment. Tafenoquine will be administered as a single oral dose for radical cure according to body weight: 25 mg for participants weighing \\\u003C5 kg, 50 mg for participants weighing ≥5 kg to \\\u003C10 kg, and 100 mg for participants weighing ≥10 kg to 12 kg. Participants will be followed for safety, efficacy, pharmacokinetics, and recurrence of P. vivax malaria for 4 months.",[47,48],"Drug: Chloroquine","Drug: Tafenoquine",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":31},"DRUG","Chloroquine","Oral chloroquine tablets (250 mg). Total dose of 25 mg\u002Fkg base divided over 3 days (Days 0, 1, and 2).",[43],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":31},"Tafenoquine","Single oral dose administered according to body weight: 25 mg for \\\u003C5 kg; 50 mg for ≥5 kg to \\\u003C10 kg; 100 mg for ≥10 kg to 12 kg.",[43],[60],{"name":61,"affiliation":62,"role":63},"Cindy Chu, MD, PhD","Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Fa Ngum Road, Vientiane, LAO PDR","PRINCIPAL_INVESTIGATOR",[65],{"name":61,"role":66,"phone":67,"phoneExt":31,"email":68},"CONTACT","+856 (0) 21 250 752","cindy@tropmedres.ac",[70,90],{"facility":71,"status":31,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Shoklo Malaria Research Unit (SMRU)","Mae Ramat","Changwat Tak","63140","Thailand","TH",{"type":78,"coordinates":79},"Point",[80,81],98.51665,16.98403,{"lat":81,"lon":80},[84,87],{"name":85,"role":66,"phone":31,"phoneExt":31,"email":86},"François Nosten","francois@tropmedres.ac",{"name":88,"role":66,"phone":31,"phoneExt":31,"email":89},"Aung Phae Phyo","AungPyaePhyo@tropmedres.ac",{"facility":91,"status":31,"city":92,"state":31,"zip":31,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Oxford University Clinical Research Unit (OUCRU)","Bình Phước","Vietnam","VN",{"type":78,"coordinates":96},[97,98],106.77636,10.66438,{"lat":98,"lon":97},[101],{"name":102,"role":66,"phone":31,"phoneExt":31,"email":103},"Nguyen Chau Hoang","chaunh@oucru.org",{"type":105,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[107],{"name":108,"class":109},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100657058","phase-2-tafenoquine-drug-levels-in-small-children-100657058",false,"NCT07835321","Tafenoquine Drug Levels in Small Children","Characterising the Pharmacokinetics of Tafenoquine Under Fed Conditions for Plasmodium Vivax Radical Cure in Children ≤12kg and >28 Days Old","TQP","Inclusion Criteria:\n\n* P. vivax mono-infection as diagnosed by RDT or microscopy\n* Quantitative G6PD activity ≥70%\n* Age \\>28 days old and weight ≤12kg\n* The parent\u002Fguardian can understand the study instructions and provide written informed consent\n* Willing to return with the participant for 4 months to follow up\n\nExclusion Criteria:\n\n* Hb \\\u003C 8 g\u002FdL\n* Severe malaria\n* Blood transfusion in the last 3 months\n* Any previous history of severe anaemia or haemolysis\n* If age is \\\u003C6 months old today: gestational age at birth \\\u003C37wk or birth weight \\\u003C2.5kg\n* Use of tafenoquine within the last 4 months\n* History of allergic response to an 8-aminoquinoline or the nationally recommended schizonticide (e.g., chloroquine, artemether-lumefantrine)\n* Use of drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters, and drugs that affect chloroquine metabolism\n* Presence of any condition which in the judgement of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. chronic disease, failure to thrive, severe malnutrition)","ALL","28 Days",{"count":121,"type":122},20,"ESTIMATED","INTERVENTIONAL",[125],"PHASE2","This study is an open label, single arm, pharmacokinetic trial. A total of 20 participants (children ≤12kg and \\>28 days old) will be enrolled. Enrollment will be competitive between Thailand and Vietnam study sites (each site will enroll as many patients that are eligible until the sample size is reached). Tafenoquine will be given concomitantly with the schizonticidal agent, chloroquine, on the day of enrolment. The participant will be admitted to hospital for observation and until the malaria smear is negative for asexual parasites on 2 consecutive days or until the schizonticidal treatment is completed, which will be approximately 3-7 days. All treatment doses will be supervised. Follow up will continue on days 7, 14, 21, and 28 then every month until month 4. Parent\u002Fguardian of participants will be instructed to follow up in between visits if participants are feeling unwell. Participants who are lost to follow up (any missed visit), who require drug re-administration after vomiting, or where at least 3 pharmacokinetic samples are not successfully drawn, will be replaced. Participants being replaced will continue in the study for safety assessments and to ensure the treatment of recurrences. The total blood drawn for this study will be 3.76 mL if the participant has no recurrences.",[128,129],"Plasmodium Vivax Malaria","Vivax Malaria",[131,56,132,133,134,135,136,137,138],"Plasmodium vivax","Radical cure","Antimalarial therapy","8-aminoquinoline","Pediatric malaria","Infant malaria","Pharmacokinetics","Pediatrics","NOT_YET_RECRUITING","2026-09-18",{"date":142,"type":143},"2026-09-22","ACTUAL",{"date":145,"type":122},"2026-09-01",{"date":147,"type":122},"2030-04",{"name":5,"class":6},2]