Infant Mortality Reduction by the Mass Administration of Azithromycin

NCT04716712 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 20-32979
• Study Type: interventional
• Target: 694,400
• Locations: 2 countries
• Sites: 3

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.

Conditions

Child Mortality

Keywords

Azithromycin; Mass Drug Administration; Child Mortality

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

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

  24 months following baseline

Secondary Outcomes (2)

• Antimicrobial Resistance (AMR)

  24 months

• Clinic Visits

  24 months

Study Arms (4)

Biannual mass oral azithromycin + child health days

ACTIVE COMPARATOR

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

Biannual mass placebo + child health days

PLACEBO COMPARATOR

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

Resistance Sub Study: Azithromycin + Child Health Days

ACTIVE COMPARATOR

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

Resistance Sub Study: Placebo + Child Health Days

PLACEBO COMPARATOR

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

Interventions

Azithromycin DRUG

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.

Also known as: Zithromax

Biannual mass oral azithromycin + child health days; Resistance Sub Study: Azithromycin + Child Health Days

Placebo DRUG

Matching identical placebo in packaging, appearance, and taste.

Biannual mass placebo + child health days; Resistance Sub Study: Placebo + Child Health Days

Eligibility Criteria

• Age: 1 Month - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Community eligibility criteria:
• Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins
• Verbal consent of the community leader is obtained
• Aged 1 to 11 months
• Living in one of the communities participating in the study

You may not qualify if:

• Inaccessible or unsafe for the study team
• Known allergy to macrolides

Sponsors & Collaborators

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

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Centre de Recherche en Sante de Nouna

Nouna, Burkina Faso

Location

Helen Keller International

Ouagadougou, Burkina Faso

Location

Related Publications (2)

• Keenan JD, Bailey RL, West SK, Arzika AM, Hart J, Weaver J, Kalua K, Mrango Z, Ray KJ, Cook C, Lebas E, O'Brien KS, Emerson PM, Porco TC, Lietman TM; MORDOR Study Group. Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa. N Engl J Med. 2018 Apr 26;378(17):1583-1592. doi: 10.1056/NEJMoa1715474.

  PMID: 29694816 BACKGROUND

• Yago-Wienne F, Toure D, Dimithe G, Khassanova R, Sidibe S, Some PN, Bamba I, Zombre V, Sie A, Bountogo M, Coulibaly B, Ouattara M, Peterson B, Arnold B, Lietman TM, Lebas E, O'Brien KS. Integration of azithromycin mass administration to 1-11-month-old children into an existing health platform to reduce child mortality: a cluster-randomised trial in Burkina Faso. BMJ Glob Health. 2026 Jan 8;11(1):e021336. doi: 10.1136/bmjgh-2025-021336.

  PMID: 41506755 DERIVED

MeSH Terms

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Thomas Lietman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Georges Dimithe

  Helen Keller International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a quadruple blinded study. Only one biostatistician and one analyst at UCSF will have the unmasking information.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: October 4, 2021
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BU (2)