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

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

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).

Sponsors & Collaborators

• Curtin University

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Papua New Guinea Institute of Medical Research

  collaborator OTHER_GOV

• Arba Minch University

  collaborator OTHER

• Jimma University

  collaborator OTHER

• Universitas Sumatera Utara

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• PathWest Laboratory Medicine WA

  collaborator OTHER_GOV

• Menzies School of Health Research

  lead OTHER

Principal Investigators

• Kamala Thriemer, Professor · Menzies School of Health Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2027-12-01

Completion

2028-04-01

Countries

• Ethiopia
• Indonesia
• Pakistan
• Papua New Guinea

Study Locations