drugset / Trial / NCT06076213

Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo

NCT06076213

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-05-01
Primary completion
2024-09-24
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemether-lumefantrine Unknown
Subject Artesunate-amodiaquine Unknown