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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
Must not have
AZM use within 7 days of ICU admission
Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at discharge (approximately 2 weeks)
Awards & highlights
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken AZM within a week before being admitted to the ICU.
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I have a heart condition or my heart beats irregularly with a QTc ≥ 450 ms.
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I am not allergic to AZM or similar drugs and my liver functions are normal.
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I needed a lot of help with breathing for more than 2 days before going to the ICU.
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I need a ventilator or extra oxygen at home.
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I have a weakened immune system due to a transplant, chemotherapy, or long-term steroid use.
Select...
I have had pyloric stenosis in the past.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Length of Hospitalization
Secondary study objectives
Duration of oxygenation
Length of ICU stay

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: AZM 20mg/kg Treatment GroupActive Control1 Intervention
Group II: Control GroupPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,647 Previous Clinical Trials
2,342,086 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
~72 spots leftby Jul 2025
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