drugset / Trial / NCT05788094

ACT vs CQ With Tafenoquine for P. Vivax Mono-infection

NCT05788094

RandomizedParallel-groupOpen-labelTreatment

Summary

In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020 ASTMH Annual Meeting) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019 NEJM; Watson et al. 2022a Elife). A tafenoquine dose of 450mg is predicted to provide \>90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.

Timeline

Start
2023-06-26
Primary completion
2026-02-28
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ARTENIMOL Small molecule 7 mg/kg
Subject Artemether Small molecule 20 mg
Subject Chloroquine Small molecule 25 mg/kg Oral
Subject Tafenoquine Small molecule 450 mg
Subject lumefantrine Small molecule 120 mg
Subject piperaquine Small molecule 55 mg/kg