Does Artemisinin Combination Treatment Reduce the Radical Curative Efficacy of High Dose Tafenoquine for Plasmodium Vivax Malaria?

What this Trial Is About

Plasmodium vivax malaria is a common and serious cause of illness in tropical regions, especially in Southeast Asia where it accounts for over half of the global burden. This malaria type can relapse multiple times due to dormant liver forms, leading to severe health issues including anemia and pregnancy loss. The trial aims to determine if a higher 450 mg dose of tafenoquine combined with Artemisinin Combination Therapies (ACTs) is effective for treating P. vivax malaria, especially where chloroquine resistance limits treatment options. Participants will receive one of three treatments: dihydroartemisinin-piperaquine plus 450 mg tafenoquine, chloroquine plus 450 mg tafenoquine, or artemether-lumefantrine plus 450 mg tafenoquine. Each drug combination is given using specific dosing schedules, such as weight-based doses of dihydroartemisinin-piperaquine over three days or chloroquine doses spread over three days. Tafenoquine is administered as a single 450 mg dose to improve convenience and adherence compared to traditional 14-day primaquine treatment. During the study, participants with confirmed P. vivax malaria will be monitored over four months with regular safety checks, blood tests, and pharmacokinetic assessments. Quantitative tests for G6PD enzyme activity will screen for risks before tafenoquine use. The main outcome is to compare the effectiveness of ACT plus tafenoquine against chloroquine plus tafenoquine in preventing malaria relapse. Researchers will also evaluate drug safety, tolerability, and oxidative activity over several time points.

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