Status:
COMPLETED
Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance
Lead Sponsor:
Sanofi
Conditions:
Malaria
Eligibility:
All Genders
Phase:
PHASE4
Brief 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. S...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00445796
Start Date
June 1 2005
Last Update
April 10 2008
Active Locations (2)
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1
Sanofi-Aventis
Yaoundé, Cameroon
2
Sanofi-Aventis
Dakar, Senegal