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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
Rationale and Abstract

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.

Study Design

ClinicalTrials.gov Identifier: NCT06148792

Study Type: Interventional
Study Phase: Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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