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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

MIRAMA 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.Check my eligibility

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.See study design

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.

MIRAMA Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am under 1 year old.

Select...

My child is between 1 to 11 months old.

MIRAMA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

All-cause mortality

Secondary outcome measures

Antimicrobial Resistance (AMR)

Clinic Visits

MIRAMA 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bill and Melinda Gates FoundationOTHER

407 Previous Clinical Trials

22,229,688 Total Patients Enrolled

2 Trials studying Child Mortality

21,060 Patients Enrolled for Child Mortality

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

14,543,155 Total Patients Enrolled

1 Trials studying Child Mortality

500 Patients Enrolled for Child Mortality

Helen Keller InternationalOTHER

31 Previous Clinical Trials

47,276 Total Patients Enrolled

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04716712 — Phase 4

Child Mortality Research Study Groups: Resistance Sub Study: Placebo + Child Health Days, Biannual mass oral azithromycin + child health days, Resistance Sub Study: Azithromycin + Child Health Days, Biannual mass placebo + child health days

Child Mortality Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT04716712 — Phase 4

Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04716712 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any past research involving the Resistance Sub Study: Azithromycin + Child Health Days?

"Currently, Resistance Sub Study: Azithromycin + Child Health Days has 55 operational clinical trials; 18 of which are in the advanced Phase 3. Though many studies are based in Albuquerque, New mexico, 694 different locations worldwide are running research for this treatment."

Answered by AI

Who could potentially qualify for participation in this experiment?

"This research endeavour is recruiting 698400 infants, ranging from one month to 11 months of age. The prospective participants must live in a community that has agreed to take part and have their leader's verbal approval as well. Additionally, they need to be affected by child mortality."

Answered by AI

Are applicants over the age of twenty eligible for this trial?

"This study is limited to infants between 1 Month and 11 Months old. On the other hand, 33 trials are available for minors while 36 clinical studies cater towards seniors."

Answered by AI

Is the Resistance Sub Study: Azithromycin + Child Health Days regimen safe for those participating?

"According to our team's assessment, the Resistance Sub Study: Azithromycin + Child Health Days has a safety rating of 3. This is due to its Phase 4 trial designation which implies that this treatment has been officially approved."

Answered by AI

What types of illnesses does the Resistance Sub Study: Azithromycin + Child Health Days protocol address?

"The Resistance Sub Study: Azithromycin + Child Health Days is prescribed to tackle genital ulcer disease (GUD) and other related afflictions, such as genus chlamydia, adult patients, and cervicitis."

Answered by AI

Have recruitments for this research study begun?

"Correct. As indicated by the information hosted on clinicaltrials.gov, this medical study is presently enrolling candidates. It was published online on October 4th 2021 and recently updated on October 11th 2022; it seeks to recruit 694,400 patients from a single location."

Answered by AI

How many participants are currently engaged in this research?

"Affirmative. According to clinicaltrials.gov, this investigation is currently accepting applications from participants; it was initially published on October 4th 2021 and updated most recently on October 11 2022. The research necessitates 694400 patients at a single site for completion."

Answered by AI