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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035305
• Other study ID #: SMC LNS Mali
• Status: Completed
• Phase: N/A
• First received: January 17, 2017
• Last updated: January 25, 2017
• Start date: August 2016
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Alliance for International Medical Action
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36717
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

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

Locations

Country	Name	City	State
Mali	Amcp/Alima	Kolokani Circle	Koulikoro region

Sponsors (7)

Lead Sponsor	Collaborator
Alliance for International Medical Action	Alliance médicale contre le paludisme, Mali, European commission for humanitarian office, Institut National de la Santé Et de la Recherche Médicale, France, Ministry of health, Mali, Programme national de lutte contre le paludisme, Mali, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fever case	Fever case is defined by an axillary temperature greater than 37.5°C 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
Secondary	Global acute malnutrition case	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
Secondary	Moderate acute malnutrition case	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
Secondary	Severe acute malnutrition case	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
Secondary	Medical referral case	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

External Links

•   Description sponsor (ALIMA) site