Malaria Clinical Trial
Official title:
Efficacy and Safety of Artesunate-amodiaquine, Artemether-lumefantrine and Dihydroartemisinine-piperaquine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of Congo: a Randomized Controlled Trial
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.
This is a phase 4, randomized, open labelled clinical trial, aiming to assess efficacy and safety of 3 ACTs in the treatment of uncomplicated malaria in the Democratic Republic of the Congo. Children diagnosed with uncomplicated Plasmodium falciparum uncomplicated malaria will be randomized and followed-up during 42 days. ;
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