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Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children

RecruitingPhase 4Ages 5 Years - 12 YearsAllCurtin University
NCT07052162 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * have a normal glucose-6-phosphate-dehydrogenase (G6PD) activity (\>70% enzyme activity) as confirmed by quantitative SD Biosensor * are Rapid Diagnostic Test negative for malaria * have not received treatment with any antimalarial in the previous 4-weeks * have no signs or symptoms of significant morbidity * have no history of hypersensitivity to primaquine * are able to attend all scheduled follow-up visits Exclusion Criteria: * have G6PD activity \<70% * test positive for malaria by rapid diagnostic test * have receive treatment with an antimalarial in the previous 4-weeks * have signs or symptoms of significant morbidities * have a history of primaquine related hypersensitivity * cannot, or are not willing, to attend all scheduled follow-up visits
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What it tests

  • Single dose tafenoquine (10 mg/kg) given with water
  • Single dose tafenoquine (10 mg/kg) given with fat
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Where

1 site
Alexishafen Health Centre
Madang, Papua New Guinea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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