High-dose daily and weekly primaquine for vivax malaria in people with reduced G6PD activity
Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
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 |
| Enrollment | 100 (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 | NCT07468513 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Manaus and 3 other locations
- Dr Marcus Lacerda — Manaus, Brazil (Recruiting)
- Arba Minch General Hospital — Arba Minch, Ethiopia (Not_yet_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)
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.