Randomized open-label trial to evaluate the efficacy of artesunate-amodiaquin for seasonal malaria chemoprevention in suburban school of Bamako, Sirak
- Conditions
- Malaria
- Registration Number
- PACTR201409000782309
- Lead Sponsor
- Malaria Research and Training Center/Faculty of Medecine and Dentistry/University of Sceinces, Techniques and Technologies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
Children aged 6-15 years;
- Enrolled in basic school Sirakoro Meguètana;
- Available and able to follow-up study visits;
- Do not show any general danger signs (inability to drink, uncontrollable vomiting, history of convulsion, lethargy, inability to sit unaided) or other signs of severe and complicated malaria falciparum according to the criteria of WHO;
- Obtaining informed consent from child parents or guardian;
- No history of hypersensitivity reactions to study drugs reported ;
- Presence of biological abnormalities identified at enrollment
- Presence of any acute illness
- Presence of chronic diseases (diabetes, High blood pressure etc.).
- Presence of an evident pregnancy or revealed by a biological test
- History of antimalarial treatment (ACTs or other) within 15 days before enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Malaria incidence defined by the number of epidoses of uncomplicated malaria in the group receiving SMC compared to the control group
- Secondary Outcome Measures
Name Time Method 1. Incidence of anemia defined by the proportion of children with a Hb level <10g/dl in both groups 2. Safety : measured by the proportion of children who had an AE or SAE 3. Acceptability of the approach as measured by a questionnaire sent to teachers and students asking their views on the disadvantages, advantages, and their adherence to the approach. 4. School success/completion rates