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An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria
Sponsor: Menzies School of Health Research
Summary
Current treatment regimens to prevent relapsing malaria are too long. A shorter higher dose treatment could improve treatment outcomes, but this needs to be balanced against increased risk of side effects. Recent data from a trial in children in Papua New Guinea (PNG) suggests a shortened treatment of 3 days is safe and effective. Our multicentre trial will assess the safety and efficacy of an ultra-short primaquine course. This trial is expected to directly influence global treatment policies.
Official title: An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria (PRIMUS)
Key Details
Gender
All
Age Range
5 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1019
Start Date
2026-06-01
Completion Date
2028-04-01
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
High dose ultra short Primaquine
High-dose, ultra-short primaquine (PQ3.5): 7mg/kg total dose given as 1mg/kg twice daily over 3.5 days (day 0, 1 and 2 morning and evening doses, and day 3 morning dose) followed by placebo as morning doses on day 4, 5 and 6.
Placebo
Matching placebo administered according to the arm schedule. Morning dose on Days 4-6 for PQ3.5 arm and Evening dose on the first 3 days for PQ 7 arm).
Locations (5)
Arba Minch University
Arba Minch, Arba Minch, Ethiopia
Jimma University
Jimma, Jimma, Ethiopia
Universitas Sumatera
Bandar Lampung, Lampung, Indonesia
Aga Khan University, Karachi
Karachi, Thatta, Pakistan
Papua New Guinea Institute of Medical Research
Port Moresby, Magang, Papua New Guinea