Background

Loss of efficacy of first-line Artemisinin combination therapies (ACTs) jeopardises current malaria control and elimination efforts and will accelerate the spread of drug resistance. New antimalarial drugs are not expected to come to the market within the next five years.

There is an urgent need to evaluate alternative treatments using combinations of existing drugs which will not fall rapidly to resistance and can be deployed immediately. The deployment of Triple Artemisinin Combination Treatments (TACT) could be part of such a strategy.

Aims

This project aims to compare the efficacy, safety and tolerability of the TACTs artemether-lumefantrine+amodiaquine and artesunate-mefloquine+piperaquine and the standard ACTs artemether-lumefantrine+placebo, and artesunate-mefloquine+placebo.

Outputs to date

In Indonesia, recruitment has not started yet. The trial documents are currently under submission to the Indonesian FDA and have been approved by The Ethics Committee of the Faculty of Medicine, University of Indonesia – Cipto Mangunkusumo Hospital on August 12th, 2022.

We anticipate fully enrolling this site with 235 P. falciparum patient subjects commencing in December 2022 before May 2023.