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ClinicalTrials.gov ID

NCT07468526

Lead Sponsor

Menzies School of Health ResearchOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

1,019Estimated

Last Update Posted

Mar 12, 2026Actual

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Apr 1, 2028Estimated

Official Title

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

Brief 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.

• Malaria

• High dose ultra short Primaquine
• Placebo

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• P. vivax peripheral parasitaemia as determined by microscopy
• G6PD normal status (G6PD activity ≥70% of the site specific adjusted male median as determined by the Standard G6PD (SD Bioline, ROK))
• Fever (temperature ≥37.5°C) or history of fever in the preceding 48 hours,
• Age ≥5 years
• Bodyweight ≥14kg
• Living in the study area and willing to be followed-up for six months

Exclusion Criteria:

• Signs or symptoms of severe malaria,
• Anaemia (defined as Hb <8g/dl) and measured by the Standard G6PD
• Pregnant or lactating
• Blood transfusion within the preceding four months
• Regular or recent use (last month) of tafenoquine, primaquine or dapsone
• Known hypersensitivity to any of the study drugs

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Menzies School of Health ResearchOTHER

Collaborators

Curtin UniversityOTHER

University of MelbourneOTHER

Papua New Guinea Institute of Medical ResearchOTHER_GOV

Arba Minch UniversityOTHER

Jimma UniversityOTHER

Universitas Sumatera UtaraOTHER

Aga Khan UniversityOTHER

PathWest Laboratory Medicine WAOTHER_GOV

danielyilmab@gmail.com+251471111458

ayodhia@usu.ac.id+628126024392

masim.beg@aku.edu+923002028490