drugset / Trial / NCT02940756

Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo

NCT02940756

RandomizedParallel-groupOpen-labelTreatment

Summary

The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to play a major role in the malaria control in the region. 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, in order to ascertain the relevance of treatment guidelines such that, 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®), artemether-lumefantrine (Coartem Dispersible®) and dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.

Timeline

Start
2017-03-15
Primary completion
2018-01-02
Completion
2018-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject ARTENIMOL Small molecule 10 mg
Subject ARTENIMOL Small molecule 20 mg
Subject ARTENIMOL Small molecule 40 mg
Subject Artemether Small molecule 20 mg
Subject Artemether Small molecule 40 mg
Subject Artemether Small molecule 60 mg
Subject Artesunate Small molecule 25 mg
Subject Artesunate Small molecule 50 mg
Subject amodiaquine Other / unclassified 67.5 mg
Subject amodiaquine Other / unclassified 135 mg
Subject lumefantrine Small molecule 120 mg
Subject lumefantrine Small molecule 240 mg
Subject lumefantrine Small molecule 360 mg
Subject piperaquine Small molecule 80 mg
Subject piperaquine Small molecule 160 mg
Subject piperaquine Small molecule 320 mg

Indications