Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo
Status:
Active, not recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Malaria remains a public health concern, despite efforts that are invested in the disease
control. The Democratic Republic of the Congo (DRC) is one of the most affected countries in
Sub Saharan Africa. Artemisinin-based combination treatments (ACTs) are recommended for the
treatment of uncomplicated malaria. However, reported cases of mutations that confer to
Plasmodium falciparum resistance to artemisinin (the main component of ACTs) constitute a
threat to malaria control, particularly in Sub Saharan Africa. Therefore, the recommendation
of the World Health Organization to conduct regularly test efficacy studies in endemic
countries is paramount.
The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ
Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 for the treatment of
uncomplicated Plasmodium falciparum malaria in eight surveillance sites around DRC.
Phase:
Phase 4
Details
Lead Sponsor:
Ministry of Public Health, Democratic Republic of the Congo
Collaborators:
Centers for Disease Control and Prevention Global Fund
Treatments:
Amodiaquine Artemether Artemether, Lumefantrine Drug Combination Artesunate Lumefantrine