Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Amodiaquine; Artesunate

Criteria

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.