Revised tafenoquine dosing for treating vivax malaria
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised
This study is testing a new weight-based dose of tafenoquine to see if it works as well or better than current treatments for people with vivax malaria.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1090 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Menzies School of Health Research Academic / other |
| Locations | 4 sites (Manaus and 3 other locations) |
| Trial ID | NCT06148792 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of a revised weight-based tafenoquine dosing regimen in patients with vivax malaria. Participants will receive a target dose of 7.5 mg/kg tafenoquine, which will be compared to a high dose of primaquine and a fixed dose of tafenoquine (300 mg). The study will assess whether the revised dosing is non-inferior to primaquine and superior to the fixed dose, while also evaluating the tolerability and safety of the new regimen. The trial will involve monitoring participants for six months to gather comprehensive data on outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with P. vivax malaria who have normal G6PD status and are experiencing fever.
Not a fit: Patients with severe malaria symptoms, anemia, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer treatment option for patients with vivax malaria.
How similar studies have performed: Other studies have shown promise with tafenoquine, but this specific revised dosing approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Manaus and 3 other locations
- Dr Marcus Lacerda — Manaus, Brazil (Recruiting)
- Arba Minch General Hospital — Arba Minch, Ethiopia (Recruiting)
- Puskesmas Hanura — Hanura, Indonesia (Not_yet_recruiting)
- Dr Moses Laman and Dr Brioni Moore — Alexishafen, Papua New Guinea (Recruiting)
Study contacts
- Principal investigator: Kamala N Thriemer, PhD — Menzies School of Health Research
- Study coordinator: Hellen Mnjala
- Email: hellen.mnjala@menzies.edu.au
- Phone: +610889468675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.