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

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201409000782309
• Date of registration: 05/03/2014
• Prospective Registration: No
• Primary sponsor: Malaria Research and Training Center/Faculty of Medecine and Dentistry/University of Sceinces, Techniques and Technologies
• Public title: Randomized open-label trial to evaluate the efficacy of artesunate-amodiaquin for seasonal malaria chemoprevention in suburban school of Bamako, Sirak
• Scientific title: Randomized open-label trial to evaluate the efficacy of artesunate-amodiaquin for seasonal malaria chemoprevention in suburban school of Bamako, Sirakoro-Meguetana, Mali
• Date of first enrolment: 15/09/2013
• Target sample size: 200
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=782
• Study type: Interventional
• Study design: Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,Simple randomisation using a randomisation table created by a computer software program,The computer generated sequence was used, the allocation was done based on the participant arrival sequence in the clinic, the first participant receive the first allocation, the code used for two arms was : 0 =No AS-AQ ; 1= AS-AQ,
• Phase: Not Applicable

Countries of recruitment

Mali

Contacts

• Name: Ogobara Doumbo
• Affiliation: Director/MRTC/DEAP/FMOS/USTTB

• Name: Mahamadou Ali Thera
• Affiliation: Professor of Parasitology-Mycology at Faculty of Medecine and Dentistry

Key inclusion & exclusion 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: - 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

Age minimum: 6 Year(s)
Age maximum: 15 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Malaria

Intervention(s)

Malaria episodes management

Artesunate-Amodiaquin

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

No 2013/76/CE/FMOS

Source(s) of Monetary Support

National Center of Scientific Research

Ethics review

Status: Approved
Approval date: 31/07/2013
Contact:

Ethic Committee of Faculty of Medecine and Dentistry