A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

ConditionVivax Malaria
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMenzies School of Health Research

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

1,090 Participants
are divided into 3 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