Malaria, Falciparum Clinical Trial
Official title:
A Comparative Assessment of the Effectiveness of Artemether Plus Lumefantrine Versus Artesunate Plus Amodiaquine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria
The purpose of this study is to compare the effectiveness and safety of two Artemisinin Combination Therapies (ACTs) for the treatment of children with uncomplicated Plasmodium falciparum malaria
Childhood mortality related to Plasmodium falciparum malaria is on the rise with more than 1
million deaths per year in Sub-Saharan Africa. In the context of growing drug-resistance to
antimalarials health officials are calling for rapid replacement of failing drugs by
combining antimalarial drugs. Artemisinin Combination Antimalarial Therapies (ACTs) are in
the focus of malaria control programmes and are recommended for first-line treatment in
African countries. ACTs have been reported to be highly effective as artemisinin derivatives
cause a rapid and substantial decrease in the parasite load when used for treating patients
with malaria and resistance to artemisinin is still lacking. However, the short half-lives
of artemisinins result in frequent recrudescent infections when used alone and therefore,
much interest lays on the choice of the combination partner drug. ACTs also have been
proposed as a means of reducing transmission by the reduction of gametocytes and of delaying
the spread of drug resistance and prolonging the therapeutic life span of. Nevertheless,
drug resistance of parasites to the respective partner drug is a matter of concern.
Artesunate-amodiaquine (AQ) and artemether-lumefantrine (AL) are two registered fixed-dose
artemisinin combination chemotherapies used in Africa which are GMP-manufactured at
industrial scale. There is still limited data from randomised, controlled trials to support
the general effectiveness of these two ACTs in Africa, including Ghana. More data is needed
to compare these two therapies to make evidence-based first-line treatment decisions.
Importantly, it is difficult to predict how combination therapy may affect the spread of
drug resistance and monitoring drug resistance markers should be embedded in these trials to
guide drug policy decision.
The aim of this open-labelled, randomised drug trial is to compare the effectiveness and
safety of artesunate-amodiaquine (Arsucam®) against artemether plus lumefantrine (Coartem®)
for the treatment of children under five years of age with uncomplicated Plasmodium
falciparum malaria.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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