drugset / Trial / NCT06148792
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
Phase 3
Recruiting
1090 enrolled
Menzies School of Health Research
Addis Ababa University · collabArba Minch University · collabCurtin University · collabEijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia · collabFundação de Medicina Tropical Dr. Heitor Vieira Dourado · collabPapua New Guinea Institute of Medical Research · collabUniversity of Melbourne · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-05-10
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Primaquine | Small molecule | 7 mg/kg | Oral |
| Subject | Tafenoquine | Small molecule | 7.5 mg/kg | Oral |
| Subject | Tafenoquine | Small molecule | 300 mg | Oral |