Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

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

Primary Objective:

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.

Secondary Objective:

To compare the clinical safety of the two treatment regimens.

Inclusion Criteria:

• weighing ≥ 10 kg
• residing in the area covered by the investigating centre throughout the entire follow-up period
• axillary temperature ≥ 37.5 degrees Celsius or history of fever within the previous 24 hours
• Plasmodium falciparum density in the blood ranging from 1000 to 100,000 asexual forms per cubic millimetre

Exclusion Criteria:

• presence of at least one sign of severe malaria or clinical danger sign : prostration, consciousness disorders, recent and repeated convulsions , respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic Blood Pressure < 70 mmHg in adults or < 50 in children, spontaneous bleeding, inability to sit or stand
• serious concomitant disease
• allergy to one of the investigational medicinal products
• pregnant women or breast-feeding women.
• documented intake of an antimalarial at a suitable dosage within seven days prior to inclusion.