Infant Mortality Reduction by the Mass Administration of Azithromycin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

694400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2026-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso

NCT03682653

Childhood Mortality

COMPLETED PHASE4

Gut and Azithromycin Mechanisms in Infants and Children II

NCT04315272

Malaria

COMPLETED PHASE4

Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali

NCT04424511

Mortality

COMPLETED PHASE3

Azithromycin for Child Survival in Niger: Mortality and Resistance Trial

NCT04224987

Mortality Resistance Bacterial Child, Only

COMPLETED PHASE4

Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali

NCT03909737

Stillbirths and Infant Mortality

ACTIVE_NOT_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Mortality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This will be a quadruple blinded study. Only one biostatistician and one analyst at UCSF will have the unmasking information.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type 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.

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching identical placebo in packaging, appearance, and taste.

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

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type 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.

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching identical placebo in packaging, appearance, and taste.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Placebo

Matching identical placebo in packaging, appearance, and taste.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zithromax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* Aged 1 to 11 months
* Living in one of the communities participating in the study