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Macrolide Antibiotic

Azithromycin for Child Mortality (MIRAMA Trial)

Phase 4

Recruiting

Led By Thomas Lietman, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 1 to 11 months

Inclusion criteria for children: Aged 1 to 11 months

Must not have

Exclusion criteria for children: Known allergy to macrolides

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will investigate the supplementation of azithromycin to help reduce child mortality rates in Burkina Faso. 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.

Who is the study for?

This trial is for babies aged 1 to 11 months living in certain regions of Burkina Faso. It's part of a program that includes vitamin A supplementation and malnutrition checks. Babies with known allergies to macrolides or those from communities unsafe for the study team cannot participate.

What is being tested?

The trial tests if giving azithromycin, an antibiotic, can reduce infant mortality when added to 'Child Health Days' activities versus a placebo. Children will receive either azithromycin or a placebo alongside vitamin A and nutrition screening.

What are the potential side effects?

Azithromycin may cause side effects like diarrhea, nausea, abdominal pain, and potential allergic reactions. However, it's generally well-tolerated in children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 1 year old.

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My child is between 1 to 11 months old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child is allergic to macrolide antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All-cause mortality

Secondary study objectives

Antimicrobial Resistance (AMR)

Clinic Visits

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Biannual mass oral azithromycin + child health daysActive Control1 Intervention

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 II: Resistance Sub Study: Azithromycin + Child Health DaysActive Control1 Intervention

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 III: Resistance Sub Study: Placebo + Child Health DaysPlacebo Group1 Intervention

Group IV: Biannual mass placebo + child health daysPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met