Infant Mortality Reduction by the Mass Administration of Azithromycin

Child Mortality Clinical Trial

— MIRAMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716712
• Other study ID #: 20-32979
• Status: Recruiting
• Phase: Phase 4
• Start date: October 4, 2021
• Est. completion date: January 30, 2026

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: Djeinam Toure
• Phone: 221 77 240 5738
• Email: dtoure[@]hki.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 694400
• Est. completion date: January 30, 2026
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 11 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Mortality

Intervention

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.
• Placebo
Matching identical placebo in packaging, appearance, and taste.

Locations

Country	Name	City	State
Burkina Faso	Centre de Recherche en Sante de Nouna	Nouna
Burkina Faso	Helen Keller International	Ouagadougou
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

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

Countries where clinical trial is conducted

United States,  Burkina Faso, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antimicrobial Resistance (AMR)	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	24 months
Secondary	Clinic Visits	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.	24 months