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

NCT03035305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36717

Last updated 2017-01-30

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Lipid-based Nutrient Supplement (LNS)

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

DRUG

Seasonal malaria chemoprevention

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

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • Alliance médicale contre le paludisme, Mali

    collaborator UNKNOWN
  • Programme national de lutte contre le paludisme, Mali

    collaborator UNKNOWN
  • United States Agency for International Development (USAID)

    collaborator FED
  • European Commission

    collaborator OTHER
  • Ministry of health, Mali

    collaborator UNKNOWN
  • Alliance for International Medical Action

    lead OTHER

Principal Investigators

  • Susan Shepherd, MD · The Alliance for International Medical Action (ALIMA)

  • Renaud Becquet, PhD · Inserm U1219 Bordeaux Population Health Center, University of Bordeaux

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Mali

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035305 on ClinicalTrials.gov