High-dose daily and weekly primaquine for vivax malaria in people with reduced G6PD activity
Official title: Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
Run by Menzies School of Health Research · NCT07468513 · Data updated 2026-11-12
This will test whether 1 mg/kg daily primaquine for 7 days is safe and works for adults with P. vivax and intermediate G6PD, and whether 0.75 mg/kg weekly primaquine is safe and works for adults with G6PD deficiency.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Menzies School of Health Research Academic / other |
| Locations | 4 sites (Manaus and 3 other locations) |
| Status | Recruiting |
| Started | May 17, 2024 |
| Main results expected | June 30, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT07468513 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with P. vivax mono-infection, fever or recent fever, hemoglobin ≥8 g/dL, and confirmed G6PD intermediate (30–<70%) or deficient (<30%) status who live near the study sites and consent to six months of follow-up are ideal candidates.
✕Probably not a fit
Pregnant or breastfeeding women, patients with severe malaria, those regularly taking hemolysis-inducing drugs, people with known hypersensitivity to study drugs, children under 18, and those with hemoglobin <8 g/dL are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This non-randomized observational study enrolls adults with P. vivax mono-infection who have reduced G6PD enzyme activity and separates them into intermediate (30–<70% activity) and deficient (<30%) groups. Patients with intermediate activity receive schizontocidal therapy plus primaquine 1 mg/kg daily for 7 days, while deficient patients receive schizontocidal therapy plus primaquine 0.75 mg/kg once weekly for 8 weeks. Participants are followed for six months to monitor safety (including hemolysis and hemoglobin changes) and recurrence of parasitemia. The study is conducted at sites in Brazil, Ethiopia, and Papua New Guinea in collaboration with Menzies School of Health Research, Curtin University, University of Melbourne, and Arba Minch University.
Why it matters
Potential benefit: If successful, this approach could expand safe radical cure options for vivax malaria in people with reduced G6PD and reduce relapse rates.
How similar studies have gone: Primaquine radical cure is well established in G6PD-normal patients and weekly primaquine has supportive evidence in G6PD-deficient individuals, but high-dose daily primaquine in intermediate G6PD patients is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • P. vivax peripheral parasitaemia (mono-infection) * G6PD intermediate or deficient status (G6PD activity 30-\<70% or ≤30% 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 * Age ≥18 years * Haemoglobin at presentation ≥8g/dl * 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 * Pregnant or lactating females * Regular use of drugs with haemolytic potential * Known hypersensitivity to any of the study drugs.
Where it's running
-
Dr Marcus Lacerda
Manaus, Brazil Recruiting -
Dr Moses Laman and Dr Brioni Moore
Alexishafen, Madang Province, Papua New Guinea Recruiting -
Papua New Guinea Institute of Medical Research
Port Moresby, Magang, Papua New Guinea Recruiting -
Arba Minch General Hospital
Arba Minch, Ethiopia Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.