A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
Recruiting now · Phase 3
Conditions studied: Vivax Malaria
In brief
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.
Key facts
- Study ID
- NCT06148792
- Run by
- Menzies School of Health Research
- People needed
- 1090
- Starts
- 2024-05-10
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2025-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Dr Marcus Lacerda — Manaus, Brazil (enrolling)
- Arba Minch General Hospital — Arba Minch, Ethiopia (enrolling)
- Dr Moses Laman and Dr Brioni Moore — Alexishafen, Papua New Guinea (enrolling)
- Puskesmas Hanura — Hanura, Indonesia
Full record on ClinicalTrials.gov
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