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Macrolide Antibiotic

Azithromycin for Pediatric Health (AVENIR Trial)

Phase 4

Recruiting

Led By Kieran O'Brien, PhD, MPH

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

At the individual-level: Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment

At the individual-level: Age 1-11 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

AVENIR Trial Summary

This trialaims to show that giving azithromycin to children 1-11 months old in high mortality settings can reduce child deaths and monitor for antimicrobial resistance.

Who is the study for?

The trial is for children aged 1-11 months in Niger, specifically from Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions. Caregivers must consent to participation. Children previously in MORDOR trials or with known macrolide allergies cannot join.Check my eligibility

What is being tested?

Azithromycin for Oral Suspension is being tested to see if it can reduce child mortality when given twice a year to infants. The study will also monitor the impact on antibiotic resistance within programmatic settings.See study design

What are the potential side effects?

While not detailed here, azithromycin may cause digestive issues like diarrhea and nausea, allergic reactions ranging from rashes to more severe responses, and could contribute to increased antibiotic resistance.

AVENIR Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 1-59 months or 7-12 years old, or I am the caregiver of an eligible child.

Select...

My child is between 1 to 11 months old.

AVENIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Load of genetic determinants of macrolide resistance from population-based samples

Prevalence of genetic determinants of macrolide resistance from population-based samples

Secondary outcome measures

Load of genetic determinants of macrolide resistance from clinic-based samples

Number of all-cause clinic visits

Prevalence of genetic determinants of macrolide resistance from clinic-based samples

AVENIR Trial Design

2Treatment groups

Active Control

Group I: Programmatic azithro 1-11Active Control1 Intervention

Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers

Group II: no interventionActive Control1 Intervention

No additional intervention.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bill and Melinda Gates FoundationOTHER

407 Previous Clinical Trials

22,674,088 Total Patients Enrolled

Ministry of Health, NigerUNKNOWN

2 Previous Clinical Trials

1,106,050 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

14,988,555 Total Patients Enrolled

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05288023 — Phase 4

Antibiotic Resistance Research Study Groups: Programmatic azithro 1-11, no intervention

Antibiotic Resistance Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT05288023 — Phase 4

Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05288023 — Phase 4

Frequently Asked Questions

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

What impact could Programmatic azithro 1-11 have on a patient's health?

"Programmatic azithro 1-11 is a Phase 4 trial and thus, has been approved. In regards to safety, Power team awarded it the highest score of 3 out of possible 3."

Answered by AI

Is this research opportunity available to individuals right now?

"By scrutinizing the information available on clinicaltrials.gov, we can ascertain that this medical trial is actively seeking participants. It was posted for initial review on December 1st 2022 and modified most recently on February 1st 2023."

Answered by AI

How many individuals have been enlisted for this clinical trial?

"Affirmative, the clinicaltrial.gov website indicates that this medical study is actively seeking individuals to participate in their research. This trial was first released on December 1st 2022 and has since been updated on February 1st 2023. The investigators are looking for 250 000 participants from one location."

Answered by AI

What is the primary intent of this medical research?

"This clinical study, which will endure for a duration of one year, seeks to measure the prevalence of genetics-based macrolide resistance amongst participants. Secondary outcomes include an estimation of relative abundance of microbial taxa at genus and species level with regard to control arms utilizing DESeq2 in conjunction with Benjamini-Hochberg correction (FDR 5%). Additionally, this trial is also closely monitoring infant mortality rate among 1-11 month old children after their first treatment as well as tracking cause specific clinic visits per month over a period of 1 year for infant aged between 1 - 59 months visiting local health centres."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Azithromycin to Reduce Childhood Mortality in Sub-saharan Africa

Keenan, Jeremy D., Robin L. Bailey, Sheila K. West, Ahmed M. Arzika, John Hart, Jerusha Weaver, Khumbo Kalua, et al.. 2018. “Azithromycin to Reduce Childhood Mortality in Sub-saharan Africa”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1715474.

clinicaltrials.govStudy

Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)

2022. "Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05288023.