Funders:
- National Health and Medical Research Council (NHMRC)
Collaborators:
- Prof Julie Simpson and Dr Megha Rajasekhar, University of Melbourne
- Prof Marcus Lacerda, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Brazil
- Dr Tamiru Shibiru, University College of Medicine and Health Science, Arba Minch University, Ethiopia
- Dr Rini Poespoprodjo, Papuan Community Health and Development Foundation, Indonesia
- Dr Ari Satyagraha, Exein, Indonesia
- Dr Brioni Moore, Curtin University, Perth
- Dr Moses Laman, Papua New Guinea Institute of Medical Research (PNGIMR)
Aim:
To assess the efficacy and safety of a higher weight based tafenoquine (TQ) dose regimen.
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
Summary:
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.
Implications for policy and practice:
The study will provide crucial evidence for dose adjustment of a novel radical cure treatment and is likely to influence treatment guidelines.
Chief Investigator:
Project Manager:
Hellen Mnjala
Contact information:
Project dates:
The trial will commence in 2024.