Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo
Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
Despite all efforts, malaria remains a public health concern, in particular in the Democratic
Republic of the Congo (DRC). The National Malaria Control program recommends
artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or
artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies
indicated that ACTs are still effective, with efficacy above the required threshold of 90%.
It is required to assess regularly the efficacy of antimalarial drugs. I In case of
increasing failure rates, alternative options can be decided ontime.
The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ
Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 in the treatment of
uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
Phase:
Phase 4
Details
Lead Sponsor:
Ministry of Public Health, Democratic Republic of the Congo
Collaborators:
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo University of Kinshasa World Health Organization
Treatments:
Amodiaquine Artemether Artemether, Lumefantrine Drug Combination Artesunate Lumefantrine