Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03035305
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Alliance médicale contre le paludisme, Mali
Programme national de lutte contre le paludisme, Mali
United States Agency for International Development (USAID)
European commission for humanitarian office
Ministry of health, Mali
Information provided by (Responsible Party):
Alliance for International Medical Action

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.


Condition or disease Intervention/treatment Phase
Malaria Dietary Supplement: Lipid-based Nutrient Supplement (LNS) Drug: Seasonal malaria chemoprevention Not Applicable

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)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36717 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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
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

Other Name: Sulfadoxine-pyrimethamine plus amodiaquine

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

Other Name: Sulfadoxine-pyrimethamine plus amodiaquine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035305


Locations
Layout table for location information
Mali
Amcp/Alima
Kolokani Circle, Koulikoro region, Mali
Sponsors and Collaborators
Alliance for International Medical Action
Institut National de la Santé Et de la Recherche Médicale, France
Alliance médicale contre le paludisme, Mali
Programme national de lutte contre le paludisme, Mali
United States Agency for International Development (USAID)
European commission for humanitarian office
Ministry of health, Mali
Investigators
Layout table for investigator information
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

Additional Information:
Layout table for additonal information
Responsible Party: Alliance for International Medical Action
ClinicalTrials.gov Identifier: NCT03035305     History of Changes
Other Study ID Numbers: SMC LNS Mali
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alliance for International Medical Action:
Seasonal malaria chemoprevention
Lipid-based nutrient supplement
Children
Mali

Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases
Nutrients
Pyrimethamine
Sulfadoxine
Amodiaquine
Fanasil, pyrimethamine drug combination
Growth Substances
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents