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A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

RecruitingPhase 3Ages 18 Years - anyAllMenzies School of Health Research
NCT06148792 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: * is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days) * is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg) * is the tolerability and safety of TQRevised acceptable * is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.

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📋 Eligibility rules (as published)
Inclusion Criteria: * P. vivax peripheral parasitaemia (mono-infection) * G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK)) * Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours * Written informed consent * Living in the study area and willing to be followed for six months Exclusion Criteria: * Danger signs or symptoms of severe malaria * Anaemia (defined as Hb \<8g/dl) * Pregnant or lactating females * Regular use of drugs with haemolytic potential * Known hypersensitivity to any of the study drugs.
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What it tests

  • Tafenoquine
  • Primaquine
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Where

4 sites
Dr Marcus Lacerda
Manaus, Brazil
Arba Minch General Hospital
Arba Minch, Ethiopia
Puskesmas Hanura
Hanura, Indonesia
Dr Moses Laman and Dr Brioni Moore
Alexishafen, 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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