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drugset / Trial / NCT04618523

Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo

NCT04618523 ↗

Phase 4 Completed 1117 enrolled Ministry of Public Health, Democratic Republic of the Congo Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo · collabUniversity of Kinshasa · collabWorld Health Organization · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-10-26
Primary completion
2022-02-08
Completion
2022-02-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemether Small molecule 20 mg Oral
Subject Artemether Small molecule 40 mg Oral
Subject Artemether Small molecule 60 mg Oral
Subject Artesunate Small molecule 25 mg Oral
Subject Artesunate Small molecule 50 mg Oral
Subject amodiaquine Other / unclassified 67.5 mg Oral
Subject amodiaquine Other / unclassified 135 mg Oral
Subject lumefantrine Small molecule 120 mg Oral
Subject lumefantrine Small molecule 240 mg Oral
Subject lumefantrine Small molecule 360 mg Oral

Indications

malaria