Infant Mortality Reduction by the Mass Administration of Azithromycin

Mortalite Infantile Reduite Par l'Administration de Masse de l'Azitromycine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04716712

Acronym

MIRAMA

Enrollment

694400

Registered

2021-01-20

Start date

2021-10-04

Completion date

2026-01-30

Last updated

2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Mortality

Keywords

Azithromycin, Mass Drug Administration, Child Mortality

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.

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.

Interventions

DRUGAzithromycin

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.

DRUGPlacebo

Matching identical placebo in packaging, appearance, and taste.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, 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.

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

Eligibility

Sex/Gender

ALL

Age

1 Months to 11 Months

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Clinic Visits	24 months	b) Evaluate whether azithromycin integrated within the VAD+ platform changes the rate of clinic visits in children aged 1-11 month old compared to placebo.

Countries

Burkina Faso, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026