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

Alliance for International Medical Action36,717 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

36,717

Conditions

Malaria

Interventions

Lipid-based Nutrient Supplement (LNS)DIETARY_SUPPLEMENT

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

Seasonal malaria chemopreventionDRUG

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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

Locations (1)

Amcp/Alima

Kolokani Circle, Koulikoro, Mali

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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