ACT MALI: Treatment of Malaria Based on Combination Therapies
Phase 4
Completed
- Conditions
- Malaria
- Interventions
- Registration Number
- NCT00452907
- Lead Sponsor
- Sanofi
- Brief Summary
Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 780
Inclusion Criteria
- Body weight > 5kg
- Residence in the investigator site area for the duration of the trial
- Axillary temperature ≥ 37,5°C at Day 0
- Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood
Exclusion Criteria
- Danger signs or signs of severe malaria
- Other severe illnesses
- Allergy to one of the drugs
- Pregnant women
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 arthemether + lumefantrine Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days 2 Artesunate + Sulfadoxine-Pyrimethamine Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os 1 Artesunate Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment
- Primary Outcome Measures
Name Time Method Clinical and parasitological cure rate at day 28 Clinical and biological tolerability During the study period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇲🇱Bougoula, Mali