Malaria Clinical Trial
Official title:
Multinational, Randomized, Comparative Study of the Efficacy and Safety of Three Therapeutic Regimens: Coarsucam™ (Artesunate + Amodiaquine Fixed-Dose Combination) Administered in 1 or 2 Intakes Per Day Versus Coartem® (Artemether + Lumefantrine) in the Treatment of Uncomplicated Plasmodium Falciparum Malaria
Primary Objective:
- To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy
on D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination),
as a single daily dose, in comparison with administration of Coartem®
(artemether+lumefantrine).
Secondary Objectives:
To compare the 3 treatment groups in terms of:
- clinical and parasitological efficacy on D14 and D28 on the global population and on
the subpopulation consisting of children aged under 5 years and that for patients aged
5 years and over
- clinical and laboratory safety
- time to parasite clearance
- time to clearance of fever
- changes in gametocytaemia
- impact on anaemia
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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