<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03035305</url>
  </required_header>
  <id_info>
    <org_study_id>SMC LNS Mali</org_study_id>
    <nct_id>NCT03035305</nct_id>
  </id_info>
  <brief_title>Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alliance for International Medical Action</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alliance médicale contre le paludisme, Mali</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Programme national de lutte contre le paludisme, Mali</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>European commission for humanitarian office</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of health, Mali</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alliance for International Medical Action</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and&#xD;
      November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali.&#xD;
&#xD;
      The objective of this study is to determine whether the association SMC and LNS reduces the&#xD;
      number of confirmed malaria cases among children 6-59 months during the monthly SMC&#xD;
      distribution sessions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main objective:&#xD;
&#xD;
      To compare confirmed cases of malaria among children aged 6-59 months between the group&#xD;
      receiving SMC combined with LNS (intervention group) and the group receiving only SMC&#xD;
      (control group) during the monthly SMC distribution sessions (4 rounds)&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      To compare among children aged 6-59 months between two groups&#xD;
&#xD;
        -  Fever cases&#xD;
&#xD;
        -  Acute malnutrition cases (global, moderate and severe)&#xD;
&#xD;
        -  Medical referral cases and their reasons&#xD;
&#xD;
      Study site:&#xD;
&#xD;
      The study is conducted in 18 health areas in Kolokani Circle, Koulikoro region, Mali. Each&#xD;
      group (intervention and control groups) is composed of 9 health areas.&#xD;
&#xD;
      Number of participants:&#xD;
&#xD;
      Between 17500 and 22000 in each group (estimation)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Confirmed malaria case</measure>
    <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</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fever case</measure>
    <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</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global acute malnutrition case</measure>
    <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</time_frame>
    <description>Global acute malnutrition is defined by MUAC &lt;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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Moderate acute malnutrition case</measure>
    <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</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe acute malnutrition case</measure>
    <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</time_frame>
    <description>Severe acute malnutrition is defined by MUAC &lt;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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical referral case</measure>
    <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</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36717</enrollment>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>SMC and LNS (intervention group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMC only (control group)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Children included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lipid-based Nutrient Supplement (LNS)</intervention_name>
    <description>For each round of SMC distribution (total of 4 rounds):&#xD;
For children aged 6-11 months: 15 sachets/month or 50g every two days for 4 weeks&#xD;
For children aged 12-59 months: 21 sachets/month or 50g per day for 3 weeks</description>
    <arm_group_label>SMC and LNS (intervention group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Seasonal malaria chemoprevention</intervention_name>
    <description>For each round of SMC distribution (total of 4 rounds):&#xD;
For children aged 6-11 months: sulfadoxine 250mg/pyrimethamine 12.5mg and amodiaquine 75mg&#xD;
For children aged 12-59 months: sulfadoxine 500mg/pyrimethamine 25mg and amodiaquine 150mg&#xD;
D1 : 1 tablet sulfadoxine-pyrimethamine + 1 tablet amodiaquine D2 : 1 tablet amodiaquine D3 : 1 tablet amodiaquine</description>
    <arm_group_label>SMC and LNS (intervention group)</arm_group_label>
    <arm_group_label>SMC only (control group)</arm_group_label>
    <other_name>Sulfadoxine-pyrimethamine plus amodiaquine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between 6 and 59 months old&#xD;
&#xD;
          -  Resident in the study area&#xD;
&#xD;
          -  Signed informed consent of the mother or the child's guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Shepherd, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Alliance for International Medical Action (ALIMA)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Renaud Becquet, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inserm U1219 Bordeaux Population Health Center, University of Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amcp/Alima</name>
      <address>
        <city>Kolokani Circle</city>
        <state>Koulikoro region</state>
        <country>Mali</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mali</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Seasonal malaria chemoprevention</keyword>
  <keyword>Lipid-based nutrient supplement</keyword>
  <keyword>Children</keyword>
  <keyword>Mali</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyrimethamine</mesh_term>
    <mesh_term>Sulfadoxine</mesh_term>
    <mesh_term>Fanasil, pyrimethamine drug combination</mesh_term>
    <mesh_term>Amodiaquine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03035305
org study id: SMC LNS Mali
nct id: NCT03035305
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
arm group label: SMC and LNS (intervention group)
arm group type: Experimental
description: 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
arm group label: SMC only (control group)
arm group type: Other
description: Children included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine
intervention type: Dietary Supplement
intervention name: Lipid-based Nutrient Supplement (LNS)
description: 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
arm group label: SMC and LNS (intervention group)
intervention type: Drug
intervention name: Seasonal malaria chemoprevention
description: 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
arm group label: SMC and LNS (intervention group)
arm group label: SMC only (control group)
other name: Sulfadoxine-pyrimethamine plus amodiaquine
criteria: 
gender: All
minimum age: 6 Months
maximum age: 59 Months
healthy volunteers: No
last name: Susan Shepherd, MD
role: Principal Investigator
affiliation: The Alliance for International Medical Action (ALIMA)
last name: Renaud Becquet, PhD
role: Principal Investigator
affiliation: Inserm U1219 Bordeaux Population Health Center, University of Bordeaux
facility: 
country: Mali
responsible party type: Sponsor
mesh term: Malaria
mesh term: Pyrimethamine
mesh term: Sulfadoxine
mesh term: Fanasil, pyrimethamine drug combination
mesh term: Amodiaquine
sharing ipd: No