About this trial
The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question\[s\] it aims to answer are:
* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days) * is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg) * is the tolerability and safety of TQRevised acceptable * is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.
Eligibility criteria
Qualifiers
P. vivax peripheral parasitaemia (mono-infection)
G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
Written informed consent
Disqualifiers
Danger signs or symptoms of severe malaria
Anaemia (defined as Hb <8g/dl)
Pregnant or lactating females
Regular use of drugs with haemolytic potential
Trial design
Treatments tested in this trial
- Tafenoquine
- Primaquine
Treatment groups
Sponsors and collaborators
Menzies School of Health Research
Lead sponsor
University of Melbourne
Collaborator
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Collaborator
Arba Minch University
Collaborator
Addis Ababa University
Collaborator
Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia
Collaborator
Curtin University
Collaborator
Papua New Guinea Institute of Medical Research
Collaborator