Clinical Trial

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Study acronym: TADORE
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-11-19; most recent amendment 2025-07-15.
Status change: Not Yet Recruiting → Recruiting 2024-08-27
Trial Details
NCT Number NCT06148792
Lead Sponsor Menzies School of Health Research
Collaborators: University of Melbourne, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Arba Minch University, Addis Ababa University, Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia, Curtin University, Papua New Guinea Institute of Medical Research
Conditions Vivax Malaria
Enrollment 1,090 participants
Start Date 2024-05-10
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-18