ATAQ EASY: Artesunate + Amodiaquine Fixed Dose Combination in the Treatment of Uncomplicated Plasmodium Falciparum Malaria
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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