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NOT YET RECRUITING
NCT07468526
PHASE3

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

Sponsor: Menzies School of Health Research

View on ClinicalTrials.gov

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

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).

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