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Clinical Trial NCT04716712 (MIRAMA) for Child Mortality is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of California, San FranciscoInfant Mortality Reduction by the Mass Administration of Azithromycin (MIRAMA)
Clinical Trial NCT04716712 (MIRAMA) is designed to study Prevention for Child Mortality. It is a Phase 4 interventional trial that is active, not recruiting, having started on October 4, 2021, with plans to enroll 694,400 participants. Led by University of California, San Francisco, it is expected to complete by January 30, 2026. The latest data from ClinicalTrials.gov was last updated on March 13, 2025.
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.
Official Title
Mortalite Infantile Reduite Par l'Administration de Masse de l'Azitromycine
Conditions
Child MortalityPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- MIRAMA
- 20-32979
NCT ID Number
Start Date (Actual)
2021-10-04
Last Update Posted
2025-03-13
Completion Date (Estimated)
2026-01-30
Enrollment (Estimated)
694,400
Study Type
Interventional
PHASE
Phase 4
Status
Active, not recruiting
Keywords
Azithromycin
Mass Drug Administration
Child Mortality
Mass Drug Administration
Child Mortality
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Factorial
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorBiannual 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 | 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 ComparatorBiannual 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 | Placebo Matching identical placebo in packaging, appearance, and taste. |
Active ComparatorResistance 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 | 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 ComparatorResistance 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 | Placebo Matching identical placebo in packaging, appearance, and taste. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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 |
Eligibility Criteria
Eligible Ages
Child
Minimum Age
1 Month
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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
Community exclusion criteria:
• Inaccessible or unsafe for the study team
Exclusion criteria for children:
• Known allergy to macrolides
University of California, San Francisco703 active trials to explore- 🏛️Helen Keller International
- 🏥Centre de Recherche en Sante de Nouna, Burkina Faso
- 🧬Bill and Melinda Gates Foundation
No contact data.
3 Study Locations in 2 Countries
California
University of California, San Francisco, San Francisco, California, 94158, United States
Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso
Helen Keller International, Ouagadougou, Burkina Faso