Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance (ATOL)
To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes.
To compare the clinical safety of the two treatment regimens.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomised, Comparative Study of the Efficacy and Safety of Arsucam® Administered as a Single Daily Intake Versus Two Daily Intakes in the Treatment of Plasmodium Falciparum Malaria Attack|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445796
|Study Director:||Valérie Lameyre||Sanofi|