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Infant Mortality Reduction by the Mass Administration of Azithromycin (MIRAMA)

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ClinicalTrials.gov Identifier: NCT04716712
Recruitment Status : Not yet recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborators:
Helen Keller International
Centre de Recherche en Sante de Nouna, Burkina Faso
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of California, San Francisco

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
Child Mortality Drug: Azithromycin Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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+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
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 24 months following baseline ]
    All-cause mortality among children aged 1-11 months 24 months after baseline


Secondary Outcome Measures :
  1. Macrolide resistant pneumococcus [ Time Frame: 24 months ]
    Prevalence of macrolide-resistant pneumococcus from nasopharyngeal swabs in children 1-59 months old 24 months after baseline

  2. Genetic determinant macrolide resistance [ Time Frame: 24 months ]
    Load of genetic determinants of resistance to macrolides from rectal swabs and nasopharyngeal swabs in children 1-59 months old 24 months after baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


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): NCT04716712


Contacts
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Contact: Fanny Fyago Wienne +226 25 36 00 23/30 fyago-wienne@hki.org
Contact: Tom Lietman, MD tom.lietman@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94158
Contact: Tom Lietman, MD       tom.lietman@ucsf.edu   
Burkina Faso
Centre de Recherche en Sante de Nouna
Nouna, Burkina Faso
Contact: Ali Sie, MD       sieali@yahoo.fr   
Helen Keller International
Ouagadougou, Burkina Faso
Contact: Fanny Yago Wienne       fyago-wienne@hki.org   
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
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Principal Investigator: Thomas Lietman, MD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04716712    
Other Study ID Numbers: 20-32979
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents