NCT06148792

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,090 (estimated)
• Sponsor: Menzies School of Health Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vivax Malaria

Interventions

Type	Name	Description
DRUG	Tafenoquine	oral treatment
DRUG	Primaquine	oral treatment

Timeline

• Start date: 2024-05-10
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2023-11-28
• Last updated: 2025-07-18

Locations

4 sites across 4 countries: Brazil, Ethiopia, Indonesia, Papua New Guinea