Artemisinin-based combination therapies (ACTs) allowed significant reductions in global malaria morbidity & mortality, but future benefits are threatened by the recent emergence of resistance to artemisinin and related drugs in Southeast Asia. It is important to evaluate alternative treatments using combinations of existing drugs that won't quickly encounter resistance and can be deployed immediately in the event of resistance in Sub-Saharan Africa.
The trial "A multicenter, randomized, controlled, non-Inferiority trial to compare the efficacy, safety & tolerability of artemisinin-based triple therapy against First-line ATC + placebo for the treatment of Plasmodium malaria uncomplicated falciparum in Africa", has sites in 8 African countries. Since observations of low incidence of QTc prolongation require further large-scale investigation & confirmation, electrocardiogram measurements are performed at baseline and at several time points to assess the effect of antimalarial drugs on QT/QTc interval. We also want to assess the extent of spread or de novo emergence of resistance to antimalarial drugs in combinations through in vivo & in vitro in-depth testing; study pharmacokinetics and drug interactions; parasite & host factors affecting treatment outcomes, and gain insight into the spread of resistance induced by population movements and parasite gene flow.
Compare the efficacy of ATCs and ATAs defined as the 42-day PCR corrected clinical and parasitological adequate response (CAPR) at each site.
Corresponding comparisons of ACTs and ATAs are as follows: AL+PBO versus AL+AQ; ASMQ+PBO versus ASMQ+PPQ.
A partial-blind, randomized, controlled, non-inferiority trial of: AL+AQ; ASMQ+PPQ; AL+PBO; ASMQ+PBO for the treatment of uncomplicated Plasmodium falciparum malaria to evaluate and compare their efficacy, safety and tolerability.
Who's Involved Besides MSF?
Mahidol Oxford Tropical Medicine Research Unit, UKAid, Burkina Faso, Democratic Republic of Congo, Guinea, Niger, Nigeria, Tanzania, Rwanda
Recruitment and follow-up completed
Tentative End date