Overview

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Status:
Not yet recruiting
Trial end date:
2027-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Menzies School of Health Research
Collaborators:
Addis Ababa University
Arba Minch University
Curtin University
Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Papua New Guinea Institute of Medical Research
Papuan Community Health and Development Foundation, Indonesia
University of Melbourne
Treatments:
Primaquine
Tafenoquine
Criteria
Inclusion Criteria:

- 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

- Living in the study area and willing to be followed for six months

Exclusion Criteria:

- Danger signs or symptoms of severe malaria

- Anaemia (defined as Hb <8g/dl)

- Pregnant or lactating females

- Regular use of drugs with haemolytic potential

- Known hypersensitivity to any of the study drugs.