A multi-centre randomised controlled non-inferiority trial to compare the efficacy, safety and tolerability of Triple Artemisinin-based Combination Therapies versus first-line ACTs + placebo for the treatment of uncomplicated Plasmodium falciparum malaria in Africa (DeTACT-AFRICA Study)

Objectives

The objectives of this project are:

1. To compare the safety and tolerability of ACTs and TACTs within and across sites and regions, including comparisons of ‘non-matching’ ACTs vs TACTs (artemether- lumefantrine + placebo To compare the safety and tolerability of ACTs and TACTs within and across sites and regions, including comparisons of ‘non-matching’ ACTs vs TACTs (artemether- lumefantrine + placebo (AL+PBO) versus artesunate-piperaquine + mefloquine (AS-PPQ+MQ), artesunate-piperaquine + placebo (AS-PPQ+PBO) versus artemether-lumefantrine + amodiaquine (AL+AQ).
2. To compare additional measures of treatment efficacy between treatment arms, including the 63-day ACPR, the post-treatment prophylactic effect of ACTs and TACTs defined as the 42-day & 63-day PCR uncorrected ACPR, gametocyte carriage, parasite clearance rates and fever clearance.
3. To assess pharmacokinetic and pharmacodynamic interactions between antimalarials in TACTs.