Malaria
Conditions
Keywords
Seasonal malaria chemoprevention, Lipid-based nutrient supplement, Children, Mali
Brief summary
SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali. The objective of this study is to determine whether the association SMC and LNS reduces the number of confirmed malaria cases among children 6-59 months during the monthly SMC distribution sessions.
Detailed description
Main objective: To compare confirmed cases of malaria among children aged 6-59 months between the group receiving SMC combined with LNS (intervention group) and the group receiving only SMC (control group) during the monthly SMC distribution sessions (4 rounds) Secondary objectives: To compare among children aged 6-59 months between two groups * Fever cases * Acute malnutrition cases (global, moderate and severe) * Medical referral cases and their reasons Study site: The study is conducted in 18 health areas in Kolokani Circle, Koulikoro region, Mali. Each group (intervention and control groups) is composed of 9 health areas. Number of participants: Between 17500 and 22000 in each group (estimation)
Interventions
DIETARY_SUPPLEMENTLipid-based Nutrient Supplement (LNS)
For each round of SMC distribution (total of 4 rounds): * For children aged 6-11 months: 15 sachets/month or 50g every two days for 4 weeks * For children aged 12-59 months: 21 sachets/month or 50g per day for 3 weeks
DRUGSeasonal malaria chemoprevention
For each round of SMC distribution (total of 4 rounds): * For children aged 6-11 months: sulfadoxine 250mg/pyrimethamine 12.5mg and amodiaquine 75mg * For children aged 12-59 months: sulfadoxine 500mg/pyrimethamine 25mg and amodiaquine 150mg D1 : 1 tablet sulfadoxine-pyrimethamine + 1 tablet amodiaquine D2 : 1 tablet amodiaquine D3 : 1 tablet amodiaquine
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Alliance médicale contre le paludisme, Mali
Programme national de lutte contre le paludisme, Mali
United States Agency for International Development (USAID)
European Commission
Ministry of health, Mali
Alliance for International Medical Action
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* Being between 6 and 59 months old * Resident in the study area * Signed informed consent of the mother or the child's guardian
Exclusion criteria
* Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed malaria case | From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks | Malaria case is confirmed by a positive malaria rapid diagnostic test. This outcome will be defined as the occurrence of at least one confirmed malaria case from the 2nd through the 4th round of SMC distribution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fever case | From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks | Fever case is defined by an axillary temperature greater than 37.5⁰C measured by electronic thermometer or notion fever within 48 hours. This outcome will be defined as the occurrence of at least one fever case from the 2nd through the 4th round of SMC distribution. |
| Global acute malnutrition case | From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks | Global acute malnutrition is defined by MUAC \<125mm (orange or red color MUAC) and/or bilateral edema. This outcome will be defined as the occurrence of at least one global acute malnutrition case from the 2nd through the 4th round of SMC distribution. |
| Moderate acute malnutrition case | From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks | Moderate acute malnutrition is defined by MUAC between 115-124mm (orange color MUAC). This outcome will be defined as the occurrence of at least one moderate acute malnutrition case from the 2nd through the 4th round of SMC distribution. |
| Severe acute malnutrition case | From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks | Severe acute malnutrition is defined by MUAC \<115mm (red color MUAC) and/or bilateral edema. This outcome will be defined as the occurrence of at least one severe acute malnutrition case from the 2nd through the 4th round of SMC distribution. |
| Medical referral case | From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks | This outcome will be defined as the occurrence of at least one illness of sufficient severity to warrant referral to the nearest medical structure for evaluation from the 2nd through the 4th round of SMC distribution. |
Countries
Mali
Outcome results
None listed