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MIRAMA: Infant Mortality Reduction by the Mass Administration of Azithromycin

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04716712
Collaborator
Helen Keller International (Other), Centre de Recherche en Sante de Nouna, Burkina Faso (Other), Bill and Melinda Gates Foundation (Other)
694,400
Enrollment
3
Locations
4
Arms
51.9
Anticipated Duration (Months)
231466.7
Patients Per Site
4461.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The MORDOR clinical trial funded by the Bill & Melinda Gates Foundation in Malawi, Tanzania, and Niger demonstrated that biannual oral azithromycin distributions to children aged 1-59 months significantly reduced child mortality. The investigators hypothesize that biannual administration of azithromycin to children aged 1-11 months will reduce mortality in this age group. The aim of the project is to demonstrate that this intervention can be scaled up and produce the same benefits on mortality as those documented in smaller, more controlled studies. Since 1986, to reduce child mortality, Burkina Faso has been administering high-dose vitamin A supplementation to children aged 6-59 months on a biannual basis through the "Child Health Days" platform. The "Child Health days" are a door-to-door distribution of vitamin A coupled with screening for acute malnutrition in children aged 6-59 months and deworming of children aged 12-59 months. This approach has been successful but expensive. A new strategy implemented since September 2017 relies on community-based health workers (CBHWs) to distribute Vitamin A in rural areas, and on community-based distributors (CDs) in urban areas. Based on expert opinion and the preliminary findings of formative research conducted by the Ministry of Health and Helen Keller International, it was agreed that the Child Health Days platform was the most appropriate platform to implement the biannual administration of azithromycin to children aged 1 to 11 months.

In this trial, mortality will be measured via complete birth history which will be collected in a subset of villages in the study area before the first treatment distribution. The study team will also conduct a baseline census of the study areas for treatment coverage estimations.

Sixty villages (30 azithromycin, 30 placebo) will contribute to the macrolide resistance outcomes, where the study team will collect rectal and nasal swabs from children 1-59 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
694400 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
The study will be a double-blind, placebo-controlled, cluster-randomized trial in which health centers (CSPS) in the 3 intervention regions will be randomized to either CHD combined with placebo (33%) or CHD combined with Azithromycin (67%), an allocation of 1:2 that favors active treatment. The allocation sequence and treatment labels will be masked to all but one biostatistician and one analyst at UCSF. The placebo will be indistinguishable from the active azithromycin. Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion to CHD+placebo or CHD+azithromycinThe study will be a double-blind, placebo-controlled, cluster-randomized trial in which health centers (CSPS) in the 3 intervention regions will be randomized to either CHD combined with placebo (33%) or CHD combined with Azithromycin (67%), an allocation of 1:2 that favors active treatment. The allocation sequence and treatment labels will be masked to all but one biostatistician and one analyst at UCSF. The placebo will be indistinguishable from the active azithromycin. Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion to CHD+placebo or CHD+azithromycin
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This will be a quadruple blinded study. Only one biostatistician and one analyst at UCSF will have the unmasking information.
Primary Purpose:
Prevention
Official Title:
Mortalite Infantile Reduite Par l'Administration de Masse de l'Azitromycine
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Jan 30, 2025
Anticipated Study Completion Date :
Jan 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Biannual mass oral azithromycin + child health days

Bi-annual Mass Azithromycin distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform

Drug: Azithromycin
Azithromycin is a macrolide-type antibiotic that is used to treat various types of infections. Previous studies in Niger have demonstrated a nearly 18% reduction in all-cause child mortality following biannual mass administration to children 1-59 months.
Other Names:
  • Zithromax

    		•
    Placebo Comparator: Biannual mass placebo + child health days

    Bi-annual Mass placebo distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform

    Drug: Placebo
    Matching identical placebo in packaging, appearance, and taste.
    Active Comparator: Resistance Sub Study: Azithromycin + Child Health Days

    Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion

    Drug: Azithromycin
    Azithromycin is a macrolide-type antibiotic that is used to treat various types of infections. Previous studies in Niger have demonstrated a nearly 18% reduction in all-cause child mortality following biannual mass administration to children 1-59 months.
    Other Names:
  • Zithromax

    		•
    Placebo Comparator: Resistance Sub Study: Placebo + Child Health Days

    Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion

    Drug: Placebo
    Matching identical placebo in packaging, appearance, and taste.

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [24 months following baseline]

      a) Evaluate whether azithromycin integrated within the VAD+ platform reduces mortality in children aged 1-11 months old compared to placebo

    Secondary Outcome Measures

    1. Antimicrobial Resistance (AMR) [24 months]

      b) To compare the cluster level load of genetic determinants of macrolides resistance in rectal samples collected from children 1-59 months old in the clusters receiving azithromycin compared to the clusters receiving placebo

    2. Clinic Visits [24 months]

      b) Evaluate whether azithromycin integrated within the VAD+ platform reduces the rate of clinic visits in children aged 1-11 month old compared to placebo.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 11 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Community eligibility criteria:

    • Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins

    • Verbal consent of the community leader is obtained

    Inclusion criteria for children:

    • Aged 1 to 11 months

    • Living in one of the communities participating in the study

    Exclusion Criteria:
    Community exclusion criteria:

    • Inaccessible or unsafe for the study team

    Exclusion criteria for children:

    • Known allergy to macrolides

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94158
    2 Centre de Recherche en Sante de Nouna Nouna Burkina Faso
    3 Helen Keller International Ouagadougou Burkina Faso

    Sponsors and Collaborators

    • University of California, San Francisco
    • Helen Keller International
    • Centre de Recherche en Sante de Nouna, Burkina Faso
    • Bill and Melinda Gates Foundation

    Investigators

    • Principal Investigator: Thomas Lietman, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT04716712
    Other Study ID Numbers:
    • 20-32979
    First Posted:
    Jan 20, 2021
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by University of California, San Francisco
    Azithromycin
    Mass Drug Administration
    Child Mortality
    Additional relevant MeSH terms:
    Azithromycin

    Study Results

    No Results Posted as of Mar 25, 2022