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Macrolide Antibiotic

Azithromycin for RSV-Induced Respiratory Failure

Phase 3

Recruiting

Led By Michele Kong, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Requiring intensive respiratory support defined as either mechanical ventilation or NIV (BiPAP or CPAP) or HFNC (at >1 L/kg/min of flow

Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at discharge (approximately 2 weeks)

Awards & highlights

Study Summary

This trial is testing whether azithromycin can help people with RSV-induced respiratory failure. The hypothesis is that it will work by affecting the MMP-9 pathway.

Who is the study for?

This trial is for children aged neonates to 2 years with RSV-induced respiratory failure, admitted to the ICU within 48 hours and requiring intensive breathing support. It's not for kids who've been on such support over 48 hours before ICU, have severe liver issues, chronic breathing needs at home, weakened immune systems, recent AZM use, heart problems or a history of pyloric stenosis.Check my eligibility

What is being tested?

The ARRC trial tests if Azithromycin (AZM) helps children with acute RSV-induced respiratory failure in the ICU. Kids are randomly placed into two groups: one receiving AZM treatment and the other serving as a control group without AZM.See study design

What are the potential side effects?

Possible side effects of Azithromycin may include allergic reactions for those sensitive to macrolides or ketolides, potential liver function changes, digestive disturbances like diarrhea or vomiting, and in rare cases heart rhythm issues.

Eligibility Criteria

Inclusion Criteria

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

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I need a machine to help me breathe.

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I am between 0-2 years old and was discharged home after birth if under 1 week old.

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I was admitted to the ICU and placed on intensive respiratory support within the last 48 hours.

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My child is in the ICU with a confirmed RSV infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at discharge (approximately 2 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at discharge (approximately 2 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at discharge (approximately 2 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Length of Hospitalization

Secondary outcome measures

Duration of oxygenation

Length of ICU stay

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: AZM 20mg/kg Treatment GroupActive Control1 Intervention

Group II: Control GroupPlacebo Group1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,280,984 Total Patients Enrolled

Michele Kong, MDPrincipal InvestigatorThe University of Alabama at Birmingham

1 Previous Clinical Trials

48 Total Patients Enrolled

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05026749 — Phase 3

Respiratory Syncytial Virus Research Study Groups: AZM 20mg/kg Treatment Group, Control Group

Respiratory Syncytial Virus Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT05026749 — Phase 3

Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05026749 — Phase 3

Frequently Asked Questions

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

How do I sign up for this opportunity to help with this research?

"This study is testing a possible new treatment for respiratory syncytial virus infections in infants. To qualify, infants must be aged between 3 days and 2 years old. This trial has the capacity to enroll 370 patients."

Answered by AI

Are people aged 50 or older being recruited for this study?

"This study is only for patients aged 3 days to 2 years old. Out of the 230 total clinical trials, this is one of 47 that specifically tests for efficacy in individuals below the age of 18."

Answered by AI

Can people with the relevant medical conditions still join this clinical trial?

"As of right now, this clinical trial is still looking for patients to enroll. The first posting was on February 27th, 2022 and the most recent update was on June 16th, 2022."

Answered by AI

Could you please explain the potential side effects of AZM 20mg/kg Treatment Group?

"Since this is a Phase 3 clinical trial, there is already some data supporting the efficacy of AZM 20mg/kg Treatment Group. Furthermore, there have been multiple rounds of data supporting its safety, so we give it a safety rating of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children

Michele Kong, MD 2022. "Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05026749.

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