<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/NCT02211729</url>
  </required_header>
  <id_info>
    <org_study_id>MR/K007319/1</org_study_id>
    <nct_id>NCT02211729</nct_id>
  </id_info>
  <brief_title>A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children</brief_title>
  <acronym>SMCAZ</acronym>
  <official_title>A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Malaria Research and Training Center, Bamako, Mali</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherche en Sciences de la Sante, Burkina Faso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine whether addition of azithromycin (AZ) to&#xD;
      Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine&#xD;
      (AQ) will provide an additional reduction in deaths and severe illness in young African&#xD;
      children. The secondary objectives include an assessment of the safety and cost-effectiveness&#xD;
      of the addition of AZ to SMC with SP+AQ.&#xD;
&#xD;
      This a double blind, randomised, placebo controlled trial. The unit of randomisation will be&#xD;
      the household. Children aged 3 - 59 months will be randomised to receive four cycles of&#xD;
      either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission&#xD;
      season.&#xD;
&#xD;
      Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59&#xD;
      months of age at the start of each period of drug administration will be eligible for&#xD;
      inclusion in the trial provided that parental consent is obtained. Children with a severe,&#xD;
      chronic illness or known allergy to one of the study drugs will be excluded.&#xD;
&#xD;
      Primary endpoint: Incidence of the combination of death or hospital admission for at least 24&#xD;
      hours, not due to trauma or elective surgery during the intervention period&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
        1. incidence of the primary endpoint during the whole study period&#xD;
&#xD;
        2. attendance at a study health centre with a nonmalaria febrile illness&#xD;
&#xD;
        3. attendance at a study health centre with malaria,&#xD;
&#xD;
        4. the prevalence of moderate anaemia at the end of each malaria transmission season,&#xD;
&#xD;
        5. nutritional status at the end of each malaria transmission season,&#xD;
&#xD;
        6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant&#xD;
           pneumococci before and at the end of each malaria transmissions season,&#xD;
&#xD;
        7. prevalence of resistance markers to SP at the end of the study,&#xD;
&#xD;
      Sample size: 19,200 children (9600 in each country) will be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>severe morbidity and mortality</measure>
    <time_frame>from the time of enrolment upto the end of malaria transmission in year 3 ( the person time at risk will be restricted to three malaria transmission seasons)</time_frame>
    <description>Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>macrolide resistant pneumococci carriage</measure>
    <time_frame>before administration of first dose of SMC and at the end of malaria transmission season in year 1, 2 and 3,</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>out patient attendance for non malaria febrile illness</measure>
    <time_frame>from enrolment until the end of malaria transmission season in year 3</time_frame>
    <description>(b) attendance at a study health centre with a febrile illness that is not due to malaria (including acute respiratory infections and diarrhoea),</description>
  </other_outcome>
  <other_outcome>
    <measure>OPD attendance for malaria</measure>
    <time_frame>from enrollment until the end of malaria transmission season in year 3</time_frame>
    <description>(c) attendance at a study health centre with RDT or microscopically proven malaria,</description>
  </other_outcome>
  <other_outcome>
    <measure>moderate anaemia</measure>
    <time_frame>at the end of each malaria transmission season in year 1, 2, and 3</time_frame>
    <description>(d) the prevalence of moderate anaemia (Hb &lt;8 g/dL) at the end of each malaria transmission season,</description>
  </other_outcome>
  <other_outcome>
    <measure>nutritional status</measure>
    <time_frame>at the end of malaria transmission season in year 1, 2 and 3</time_frame>
    <description>(e) nutritional status at the end of each malaria transmission season,</description>
  </other_outcome>
  <other_outcome>
    <measure>nasopharyngeal carriage</measure>
    <time_frame>before the administration of first dose of SMC and at the end of malaria transmission season in year 1, 2, and 3</time_frame>
    <description>(f) the prevalence of nasopharyngeal carriage with pneumococci before and at the end of each malaria transmissions season,</description>
  </other_outcome>
  <other_outcome>
    <measure>SP resistance markers</measure>
    <time_frame>at the end of the malaria transmission season in year 3</time_frame>
    <description>(h) the prevalence of resistance markers to SP in children with Plasmodium falciparum malaria at the end of the study,</description>
  </other_outcome>
  <other_outcome>
    <measure>adverse events</measure>
    <time_frame>7 days after administration of SMC in rounds 1, 2, 3 and 4 in year one</time_frame>
    <description>solicited adverse events 7 days after administration of SMC+AZ after each round in the year one of the study</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22090</enrollment>
  <condition>Malaria</condition>
  <condition>Respiratory Infections</condition>
  <arm_group>
    <arm_group_label>Seasonal malaria chemoprevention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sulphadoxine-Pyrimethamine Amodiaquine Placebo Azithromycin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>seasonal malaria chemoprevention plus AZ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sulphadoxine-Pyrimethamine+ Amodiaquine + Azithromycin 4 rounds during malaria transmission season</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin</intervention_name>
    <description>Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season</description>
    <arm_group_label>seasonal malaria chemoprevention plus AZ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin</intervention_name>
    <description>Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season</description>
    <arm_group_label>Seasonal malaria chemoprevention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children of either sex aged 3-59 months of age at the start of each period of drug&#xD;
             administration&#xD;
&#xD;
          -  parental consent is obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a severe, chronic illness,&#xD;
&#xD;
          -  a known allergy to one of the study drugs.&#xD;
&#xD;
          -  HIV+ children on cotrimoxazole prophylaxis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hounde district Hospital</name>
      <address>
        <city>Hounde</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bougouni Koulikoro District hospital</name>
      <address>
        <city>Bougouni</city>
        <country>Mali</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
    <country>Mali</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>March 6, 2018</last_update_submitted>
  <last_update_submitted_qc>March 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <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>
  <!-- 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/NCT02211729
org study id: MR/K007319/1
nct id: NCT02211729
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The primary objective of this study is to determine whether addition of azithromycin (AZ) to
      Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine
      (AQ) will provide an additional reduction in deaths and severe illness in young African
      children. The secondary objectives include an assessment of the safety and cost-effectiveness
      of the addition of AZ to SMC with SP+AQ.

      This a double blind, randomised, placebo controlled trial. The unit of randomisation will be
      the household. Children aged 3 - 59 months will be randomised to receive four cycles of
      either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission
      season.

      Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59
      months of age at the start of each period of drug administration will be eligible for
      inclusion in the trial provided that parental consent is obtained. Children with a severe,
      chronic illness or known allergy to one of the study drugs will be excluded.

      Primary endpoint: Incidence of the combination of death or hospital admission for at least 24
      hours, not due to trauma or elective surgery during the intervention period

      Secondary endpoints:

        1. incidence of the primary endpoint during the whole study period

        2. attendance at a study health centre with a nonmalaria febrile illness

        3. attendance at a study health centre with malaria,

        4. the prevalence of moderate anaemia at the end of each malaria transmission season,

        5. nutritional status at the end of each malaria transmission season,

        6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant
           pneumococci before and at the end of each malaria transmissions season,

        7. prevalence of resistance markers to SP at the end of the study,

      Sample size: 19,200 children (9600 in each country) will be enrolled.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: severe morbidity and mortality
time frame: from the time of enrolment upto the end of malaria transmission in year 3 ( the person time at risk will be restricted to three malaria transmission seasons)
description: Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period.
measure: macrolide resistant pneumococci carriage
time frame: before administration of first dose of SMC and at the end of malaria transmission season in year 1, 2 and 3,
measure: out patient attendance for non malaria febrile illness
time frame: from enrolment until the end of malaria transmission season in year 3
description: (b) attendance at a study health centre with a febrile illness that is not due to malaria (including acute respiratory infections and diarrhoea),
measure: OPD attendance for malaria
time frame: from enrollment until the end of malaria transmission season in year 3
description: (c) attendance at a study health centre with RDT or microscopically proven malaria,
measure: moderate anaemia
time frame: at the end of each malaria transmission season in year 1, 2, and 3
description: (d) the prevalence of moderate anaemia (Hb <8 g/dL) at the end of each malaria transmission season,
measure: nutritional status
time frame: at the end of malaria transmission season in year 1, 2 and 3
description: (e) nutritional status at the end of each malaria transmission season,
measure: nasopharyngeal carriage
time frame: before the administration of first dose of SMC and at the end of malaria transmission season in year 1, 2, and 3
description: (f) the prevalence of nasopharyngeal carriage with pneumococci before and at the end of each malaria transmissions season,
measure: SP resistance markers
time frame: at the end of the malaria transmission season in year 3
description: (h) the prevalence of resistance markers to SP in children with Plasmodium falciparum malaria at the end of the study,
measure: adverse events
time frame: 7 days after administration of SMC in rounds 1, 2, 3 and 4 in year one
description: solicited adverse events 7 days after administration of SMC+AZ after each round in the year one of the study
arm group label: Seasonal malaria chemoprevention
arm group type: Active Comparator
description: Sulphadoxine-Pyrimethamine Amodiaquine Placebo Azithromycin
arm group label: seasonal malaria chemoprevention plus AZ
arm group type: Experimental
description: Sulphadoxine-Pyrimethamine+ Amodiaquine + Azithromycin 4 rounds during malaria transmission season
intervention type: Drug
intervention name: Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin
description: Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season
arm group label: seasonal malaria chemoprevention plus AZ
intervention type: Drug
intervention name: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin
description: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season
arm group label: Seasonal malaria chemoprevention
criteria: 
gender: All
minimum age: 3 Months
maximum age: 59 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Burkina Faso
country: Mali
responsible party type: Sponsor
mesh term: Malaria
mesh term: Respiratory Tract Infections
mesh term: Azithromycin
mesh term: Pyrimethamine
mesh term: Sulfadoxine
mesh term: Fanasil, pyrimethamine drug combination
mesh term: Amodiaquine