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Last Updated: 09/05/2024
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria (TADORE)
Objectives
To assess the efficacy and safety of a higher weight based tafenoquine (TQ) dose regimen.
Specific objectives:
- To compare the antirelapse efficacy of a revised weight-based TQ regimen (TQ Revised: target dose 7.5mg/kg) with high dose primaquine (PQ7: 7mg/kg over 7 days)
- To compare the antirelapse efficacy of TQ Revised with the fixed-dose TQ regimen (TQ Standard: 300mg fixed dose)
- To compare the tolerability and safety of TQ Revised, TQ Standard and PQ7
- To understand feasibility and acceptability of a weight-based TQ dosing scheme
University of Melbourne (UoM), Australia
Doctor Heitor Vieira Dourado Foundation for Tropical Medicine (FMT-HVD), Brazil
Arba Minch University (AMU), Ethiopia
Addis Ababa University, Ethiopia
Papuan Community Health and Development Foundation (PHCDF), Indonesia
Exein Health Initiative (EHI), Indonesia
Curtin University, Australia
Papua New Guinea Institute of Medical Research (PNGIMR), Papua New Guinea
TQ, as a single dose regimen, has significant advantages over the longer courses of PQ needed to achieve radical cure of P. vivax. The current data available show that the recommended fixed dose of 300mg TQ in adults is too low and compromised by a lack of weight-based dosing. To ensure maximal impact on health outcomes, the recommended dose for TQ must be optimised for clinical practice. Our study will assess the efficacy and safety of a higher weight based TQ dose regimen.
The study will provide crucial evidence for dose adjustment of a novel radical cure treatment and is likely to influence treatment guidelines.
ClinicalTrials.gov Identifier: NCT06148792
Study Type: Interventional
Study Phase: Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Apr 2024 — Mar 2027
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