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

NCT03035305 | Completed

• 1 other identifier: SMC LNS Mali
• Study Type: interventional
• Target: 36,717
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Seasonal malaria chemoprevention; Lipid-based nutrient supplement; Children; Mali

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

SMC and LNS (intervention group)

EXPERIMENTAL

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); Drug: Seasonal malaria chemoprevention

SMC only (control group)

OTHER

Children included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine

Drug: Seasonal malaria chemoprevention

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

SMC and LNS (intervention group)

Seasonal malaria chemoprevention DRUG

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

Also known as: Sulfadoxine-pyrimethamine plus amodiaquine

SMC and LNS (intervention group); SMC only (control group)

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being between 6 and 59 months old
• Resident in the study area
• Signed informed consent of the mother or the child's guardian

You may not qualify if:

• Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine

Sponsors & Collaborators

• Alliance for International Medical Action: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Alliance médicale contre le paludisme, Mali: collaborator
• Programme national de lutte contre le paludisme, Mali: collaborator
• United States Agency for International Development (USAID): collaborator
• European Commission: collaborator
• Ministry of health, Mali: collaborator

Study Sites (1)

Amcp/Alima

Kolokani Circle, Koulikoro, Mali

Location

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination; Amodiaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Susan Shepherd, MD

  The Alliance for International Medical Action (ALIMA)

  PRINCIPAL INVESTIGATOR

• Renaud Becquet, PhD

  Inserm U1219 Bordeaux Population Health Center, University of Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 30, 2017
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 30, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)