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Randomized open-label trial to evaluate the efficacy of artesunate-amodiaquin for seasonal malaria chemoprevention in suburban school of Bamako, Sirak

Randomized open-label trial to evaluate the efficacy of artesunate-amodiaquin for seasonal malaria chemoprevention in suburban school of Bamako, Sirakoro-Meguetana, Mali

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201409000782309
Enrollment
200
Registered
2014-03-05
Start date
2013-09-15
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Malaria episodes management
Artesunate-Amodiaquin

Sponsors

Malaria Research and Training Center/Faculty of Medecine and Dentistry/University of Sceinces, Techniques and Technologies
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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 ;

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
Malaria incidence defined by the number of epidoses of uncomplicated malaria in the group receiving SMC compared to the control group

Secondary

MeasureTime frame
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

Countries

Mali

Contacts

Public ContactOgobara Doumbo

Director/MRTC/DEAP/FMOS/USTTB

okd@icermali.org(223) 20 22 81 09

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026