NCT07468526

An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria

An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria (PRIMUS)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,019 (estimated)
• Sponsor: Menzies School of Health Research · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	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.
OTHER	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).

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-12-01
• Completion: 2028-04-01
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

5 sites across 4 countries: Ethiopia, Indonesia, Pakistan, Papua New Guinea