- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03035305
Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Koulikoro region
-
Kolokani Circle, Koulikoro region, Mali
- Amcp/Alima
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMC and LNS (intervention group)
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
|
For each round of SMC distribution (total of 4 rounds):
For each round of SMC distribution (total of 4 rounds):
D1 : 1 tablet sulfadoxine-pyrimethamine + 1 tablet amodiaquine D2 : 1 tablet amodiaquine D3 : 1 tablet amodiaquine
Other Names:
|
Other: SMC only (control group)
Children included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine
|
For each round of SMC distribution (total of 4 rounds):
D1 : 1 tablet sulfadoxine-pyrimethamine + 1 tablet amodiaquine D2 : 1 tablet amodiaquine D3 : 1 tablet amodiaquine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmed malaria case
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
|
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
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
|
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
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 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
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 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
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 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
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
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Susan Shepherd, MD, The Alliance for International Medical Action (ALIMA)
- Principal Investigator: Renaud Becquet, PhD, Inserm U1219 Bordeaux Population Health Center, University of Bordeaux
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Infective Agents, Urinary
- Renal Agents
- Pyrimethamine
- Sulfadoxine
- Fanasil, pyrimethamine drug combination
- Amodiaquine
Other Study ID Numbers
- SMC LNS Mali
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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