Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance
Phase 4
Completed
- Conditions
- Malaria
- Registration Number
- NCT00445796
- Lead Sponsor
- Sanofi
- 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.
Secondary Objective:
To compare the clinical safety of the two treatment regimens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method clinical and parasitological cure on Day 14 Secondary: incidence and severity of adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis
🇸🇳Dakar, Senegal