Clinical trial NCT03035305: Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: Seasonal malaria chemoprevention
Lipid-based nutrient supplement
Children
Mali
Lead sponsor: Alliance for International Medical Action
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Alliance médicale contre le paludisme, Mali
name: Programme national de lutte contre le paludisme, Mali
name: United States Agency for International Development (USAID)
name: European Commission
name: Ministry of health, Mali
First posted: 2017-01-30
Enrollment: 36717
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Confirmed malaria case
timeFrame: 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:
measure: Fever case
timeFrame: 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
measure: Global acute malnutrition case
timeFrame: 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
measure: Moderate acute malnutrition case
timeFrame: 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
measure: Severe acute malnutrition case
timeFrame: 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
measure: Medical referral case
timeFrame: 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
Other outcomes:
Locations:
city: Kolokani Circle
country: Mali
facility: Amcp/Alima
state: Koulikoro region
Study officials:
affiliation: The Alliance for International Medical Action (ALIMA)
name: Susan Shepherd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inserm U1219 Bordeaux Population Health Center, University of Bordeaux
name: Renaud Becquet, PhD
role: PRINCIPAL_INVESTIGATOR
References: