Efficacy and safety of Triple ACTs compared to conventional ACTs for the treatment of uncomplicated malaria : DETACT trial
Study design
Multicenter, partially blinded, randomized, controlled, non-inferiority trial
Context
Artemisinin-based combination therapies (ACTs) have made a major contribution to substantial reductions in malaria morbidity and mortality worldwide over the past decade. However, future benefits are threatened by the recent emergence of resistance to artemisinin and related drugs in Asia and Africa. This study aims to evaluate alternative treatments using combinations of existing drugs.
Our Role
Study Site
Partners
- Mahidol Oxford Tropical Medicine Research Unit
- UKAid
- Ministries of Health of Burkina Faso, the DRC, Guinea, Niger, Nigeria, Tanzania and Rwanda
Objective
Compare the efficacy, tolerability and safety of artemisinin-based triple therapies (artemether-lumefantrine+amodiaquine, artesunate-mefloquine+piperaquine) and ACTs (artemether-lumefantrine+placebo, artesunate-mefloquine+placebo)
Preliminary results In Niger
A better post-treatment prophylactic effect with TACT than with ACT. No differences in fever disappearance and parasite clearance between ACT and TACT. More vomiting recorded with TACT. Liver and kidney parameters comparable between arms. No cardiac safety issues noted. No signs of artemisinin resistance were found at the Niger study site. Further results are awaited on PCR-corrected efficacy, pharmacokinetics, pharmacodynamics, and those of the other study sites.
