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

ConditionMalaria

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age5+

SponsorMenzies School of Health Research

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

High dose ultra short Primaquine
Placebo

Treatment groups

1,019 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Menzies School of Health Research

Lead sponsor

Curtin University

Collaborator

University of Melbourne

Collaborator

Papua New Guinea Institute of Medical Research

Collaborator

Arba Minch University

Collaborator

Jimma University

Collaborator

Universitas Sumatera Utara

Collaborator

Aga Khan University

Collaborator

PathWest Laboratory Medicine WA

Collaborator

Source ClinicalTrials.gov