Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali

Study Overview
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Brief Summary
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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
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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)

Official Title
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Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Kolokani Circle, Koulikoro Region, Mali, August-November 2016: Interventional Matched-pair Clustered Cohort

Conditions
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Malaria

Intervention / Treatment
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* Dietary Supplement: Lipid-based Nutrient Supplement (LNS)
* Drug: Seasonal malaria chemoprevention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMC and LNS (intervention group)<br>Children included in the 9 health areas of the intervention group receiving both lipid-based nutrient supplement and seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine | Dietary Supplement: Lipid-based Nutrient Supplement (LNS)<br>* 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<br>Drug: Seasonal malaria chemoprevention<br>* 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<br>* Other names: Sulfadoxine-pyrimethamine plus amodiaquine;|
| Other: SMC only (control group)<br>Children included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine | Drug: Seasonal malaria chemoprevention<br>* 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<br>* Other names: Sulfadoxine-pyrimethamine plus amodiaquine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed malaria case | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever case | 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. | 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 case | 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. | 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 case | 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. | 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 case | 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. | 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 | 
| Medical referral case | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seasonal malaria chemoprevention, Lipid-based nutrient supplement, Children, Mali