[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Papua New Guinea\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":167},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,76,102,125,146],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100597585","phase-2-postpartum-8-aminoquinoline-breast-milk-study-100597585",false,"NCT07060404","Postpartum 8-aminoquinoline Breast Milk Study","Pharmacokinetics of Primaquine and Tafenoquine in Lactating Women - Towards Equitable Radical Cure of Vivax Malaria","Inclusion Criteria:\n\n1. ≥18 years of age\n2. Both mother and infant have G6PD activity \\>70% (normal activity; SD Biosensor)\n3. They have no significant co-morbidity\n4. Delivered a live singleton baby within past 48-hours\n5. Rapid diagnostic test negative for malaria\n6. No history of hypersensitivity to 8-aminoquinoline drugs\n7. Plan to exclusively breastfeed for at least two months\n8. History of vivax malaria (as per health book)\n9. They can attend follow-up assessments for the duration of the study\n\nExclusion Criteria:\n\n1. Either mother\u002Finfant have G6PD activity \\\u003C70% (SD Biosensor)\n2. Either mother\u002Finfant have significant co-morbidity\n3. Mother did not deliver a live singleton within past 48-hours\n4. Mother\u002Finfant are rapid diagnostic test positive for malaria\n5. Mother has a history of hypersensitivity to 8-aminoquinoline drugs\n6. Mother does not plan to exclusively breastfeed for at least two months\n7. Mother does not have a history of vivax malaria (as per health book)\n8. Cannot or are not willing to attend follow-up assessments for the duration of the study",true,"FEMALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","In Papua New Guinea, administration of primaquine (PQ) or tafenoquine (TQ) to breastfeeding mothers is contraindicated during the first six months postpartum, when infants are recommended to be exclusively breastfed, because of a lack of comprehensive pharmacokinetic data on PQ\u002FTQ neonatal and infant exposure via breast milk. The therapeutic restriction of PQ\u002FTQ use in lactating women during the first six months postpartum effectively translates into \\~10% of females being excluded from radical cure in endemic areas at any time. This is because many at risk women live in remote areas, are frequently lost to follow-up, or may have conceived again before they reattend. As a result, radical cure is rarely achieved and women are exposed to recurrent infections and cumulative risk of anaemia. Relapses may occur for years, placing subsequent pregnancies at risk and perpetuating intergenerational failure of fetal growth. They also contribute to malaria transmission, thus household and community exposure to vivax malaria.\n\nThe goal of the present study is to determine how much PQ\u002FTQ is transferred to a suckling baby, if a mother receives a treatment course of PQ\u002FTQ at time of delivery. We also want to confirm that this treatment is safe and has no major side effects for babies in Papua New Guinea.\n\nThe study Interventions areas follows: Group 1 - Participants receive PNG standard of care; PQ given 6-months postpartum; Group 2 - Participants receive a 14-day treatment regimen of PQ, at the standard dose prescribed in PNG for vivax radical cure (0.5 mg\u002Fkg\u002Fday for 14 days); Group 3 - Participants receive an accelerated high-dose 7-day treatment regimen of PQ, as per current WHO recommendations (1.0 mg\u002Fkg\u002Fday for 7 days); Group 4 - Participants receive a single dose of 300mg tafenoquine.\n\nAll participants will be monitored for a total duration of 6 months, with the safety, tolerability, pharmacokinetics and preliminary relapse efficacy of PQ\u002FTQ evaluated at standardised time points over this period (Day 0, 1, 3, 6, 8, 15, 20, 28, and Month 2, 3, 4, 5 and 6). At each of these time points, participants will be asked to describe any symptoms they may be experiencing, participate in a medical examination, and provide a blood and breast milk sample for drug analysis and safety (biochemistry and haematology testing). The investigators will also collect a small blood sample (heel prick) from the infant to measure drug concentrations and safety testing.",[28],"Drug Pharmacokinetics in Healthy Volunteers",[30,31,32,33,34,35,36],"primaquine","tafenoquine","vivax malaria","pharmacokinetics","postpartum","lactation","infant exposure","NOT_YET_RECRUITING","2026-03-16",{"date":40,"type":41},"2026-03-18","ACTUAL",{"date":43,"type":21},"2026-04",{"date":45,"type":21},"2027-05",{"name":47,"class":48},"Curtin University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100596952","phase-4-investigating-the-pharmacokinetics-of-tafenoquine-in-healthy-papua-new-guinean-children-100596952","NCT07052162","Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children","Safety, Pharmacokinetics, and Preliminary Efficacy of Tafenoquine for the Treatment of Vivax Malaria in Papua New Guinean Children","Inclusion Criteria:\n\n* have a normal glucose-6-phosphate-dehydrogenase (G6PD) activity (\\>70% enzyme activity) as confirmed by quantitative SD Biosensor\n* are Rapid Diagnostic Test negative for malaria\n* have not received treatment with any antimalarial in the previous 4-weeks\n* have no signs or symptoms of significant morbidity\n* have no history of hypersensitivity to primaquine\n* are able to attend all scheduled follow-up visits\n\nExclusion Criteria:\n\n* have G6PD activity \\\u003C70%\n* test positive for malaria by rapid diagnostic test\n* have receive treatment with an antimalarial in the previous 4-weeks\n* have signs or symptoms of significant morbidities\n* have a history of primaquine related hypersensitivity\n* cannot, or are not willing, to attend all scheduled follow-up visits","ALL","5 Years","12 Years",{"count":61,"type":21},30,[63],"PHASE4","Plasmodium vivax is the most geographically widespread malaria species and the second largest contributor to symptomatic malaria worldwide. It accounts for half of all malaria cases outside Africa, with an estimated 14.3 million clinical vivax malaria cases reported annually, contributing to an annual cost of US$359 million. Children are most vulnerable to infection, with P. vivax prevalence peaking between 2 to 6 years of age. In Papua New Guinea (PNG), there are \\>1.5 million suspected P. vivax cases annually, and while P. falciparum infections are the most prevalent, P. vivax transmission is the most intense in the world. P. vivax in PNG provides a unique epidemiological setting in which to assess innovative treatments in children.\n\nThe complex biology of P. vivax represents a challenge for malaria control and chemotherapy, especially dormant liver-stage parasites (hypnozoites) which can reactivate (relapse) and cause disease at a time remote from the primary infection. Hypnozoite relapse is the primary cause of vivax malaria in endemic regions and is resistant to most antimalarial drugs. Identifying effective treatments for radical cure, the complete elimination of parasites (both blood- and liver-stage), is therefore a priority. The World Health Organization (WHO) recommends a 14-day radical cure regimen for uncomplicated vivax malaria; comprised of blood stage treatment (chloroquine or artemisinin combination therapy (ACT)) and 14 days of the 8-aminoquinoline drug primaquine (PQ; 0.25-0.5 mg\u002Fkg\u002Fday) for liver-stage cure. More recently, the 8-aminoquinoline tafenoquine has garnered interest as an alternative radical cure agent to primaquine. However, there is limited data on the pharmacokinetics, tolerability and radical cure efficacy of tafenoquine in children.\n\nThe overall aim of the study is to characterise the pharmacokinetic profile of tafenoquine (and primary metabolite) in Papua New Guinean children.",[66],"Pharmacokinetics of Tafenoquine",[31,32,33,68],"children","RECRUITING",{"date":40,"type":41},{"date":72,"type":41},"2025-10-20",{"date":74,"type":21},"2026-03",{"name":47,"class":48},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100628967","phase-3-an-ultra-short-course-of-primaquine-for-the-radical-cure-of-vivax-malaria-100628967","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",{"count":85,"type":21},1019,[25],"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.",[89],"Malaria",[91,82],"An ultra-short course of primaquine for the radical cure of vivax malaria","2026-03-09",{"date":94,"type":41},"2026-03-12",{"date":96,"type":21},"2026-06-01",{"date":98,"type":21},"2028-04-01",{"name":100,"class":48},"Menzies School of Health Research",5,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100628966","phase-4-primaquine-for-vivax-malaria-in-g6pd-intermediate-and-deficient-cases-100628966","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.",{"count":109,"type":21},100,[63],"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)",[113,114],"Vivax Malaria","G6PD Deficiency",[116,117],"Primaquine in G6PD deficiency","Vivax malaria in G6PD deficient patients",{"date":94,"type":41},{"date":120,"type":41},"2024-05-17",{"date":122,"type":21},"2028-12-31",{"name":100,"class":48},4,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":55,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":57,"minAge":131,"maxAge":59,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":145,"locationsCount":49},"100623977","phase-4-investigating-the-pharmacology-of-tafenoquine-in-papua-new-guinean-children-with-uncomplicated-malaria-100623977","NCT07403643","Investigating the Pharmacology of Tafenoquine in Papua New Guinean Children With Uncomplicated Malaria","Inclusion Criteria:\n\n* Have normal G6PD activity (\\>70% enzyme activity) as confirmed by quantitative SD Biosensor\n* Do not have severe malaria (by WHO criteria)\n* Have rapid diagnostic test and\u002For microscopically confirmed uncomplicated malaria (any species)\n* Have no significant co-morbidity\n* Have no history of hypersensitivity to primaquine\n* Have no history of hypersensitivity to artemether-lumefantrine or dihydroartemisinin-piperaquine\n* Are able to attend all scheduled follow-up visits\n\nExclusion Criteria:\n\n* Have \\\u003C70% G6PD enzyme activity, as confirmed by quantitative SD Biosensor\n* Have signs or symptoms of severe malaria (by WHO criteria)\n* Test negative for malaria by rapid diagnostic test and\u002For microscopy\n* Have signs or symptoms of a significant co-morbidity\n* Have a history of hypersensitivity to primaquine\n* Have a history of hypersensitivity to artemether-lumefantrine or dihydroartemisinin-piperaquine\n* Cannot, or are not willing, to attend all scheduled follow-up visits","2 Years",{"count":20,"type":21},[63],"Plasmodium vivax is the most geographically widespread malaria species and the second largest contributor to symptomatic malaria worldwide. It accounts for half of all malaria cases outside Africa, with an estimated 14.3 million clinical vivax malaria cases reported annually, contributing to an annual cost of US$359 million. Children are most vulnerable to infection, with P. vivax prevalence peaking between 2 to 6 years of age. In Papua New Guinea (PNG), there are \\>1.5 million suspected P. vivax cases annually, and while P. falciparum infections are the most prevalent, P. vivax transmission is the most intense in the world. P. vivax in PNG provides a unique epidemiological setting in which to assess innovative treatments in children.The complex biology of P. vivax represents a challenge for malaria control and chemotherapy, especially dormant liver-stage parasites (hypnozoites) which can reactivate (relapse) and cause disease at a time remote from the primary infection. Hypnozoite relapse is the primary cause of vivax malaria in endemic regions and is resistant to most antimalarial drugs. Identifying effective treatments for radical cure, the complete elimination of parasites (both blood- and liver-stage), is therefore a priority. The World Health Organization (WHO) recommends a 14-day radical cure regimen for uncomplicated vivax malaria; comprised of blood stage treatment (chloroquine or artemisinin combination therapy (ACT)) and 14 days of the 8-aminoquinoline drug primaquine (PQ; 0.25-0.5 mg\u002Fkg\u002Fday) for liver-stage cure. More recently, the 8-aminoquinoline tafenoquine has garnered interest as an alternative radical cure agent to primaquine. However, there is limited data on the pharmacokinetics, tolerability and radical cure efficacy of tafenoquine in children. Furthermore, early data suggest a drug interaction between TQ and artemisinin combination therapy (ACT) drugs - which requires further investigation and confirmation. This study will generate critical paediatric safety, tolerability, pharmacokinetic, and preliminary efficacy data for TQ when administered with either artemether-lumefantrine or dihydroartemisinin-piperaquine in PNG children with uncomplicated malaria.",[136],"Uncomplicated Malaria",[31,32,138,33,68],"radical cure","2026-02-10",{"date":141,"type":41},"2026-02-12",{"date":43,"type":21},{"date":144,"type":21},"2026-12",{"name":47,"class":48},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":124},"100527517","phase-3-a-revised-tafenoquine-dose-to-improve-radical-cure-for-vivax-malaria-100527517","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.",{"count":155,"type":21},1090,[25],"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.",[113],"2025-07-15",{"date":161,"type":41},"2025-07-18",{"date":163,"type":41},"2024-05-10",{"date":165,"type":21},"2027-03-01",{"name":100,"class":48},""]