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

February 4, 2026 updated by: Michele Kong, MD, University of Alabama at Birmingham
The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The proposed study will be a randomized, double-blinded, placebo-controlled Phase III trial to examine the efficacy of AZM therapy relative to placebo in reducing RSV-related morbidity. Patients will be recruited during acute hospitalization and admission to the ICU at 10 pediatric hospitals. The target population selected is pediatric patients with severe RSV lung disease as defined by need for ICU management and intensive respiratory support.

Study Type

Interventional

Enrollment (Estimated)

370

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Michele Kong, MD
    • California
      • San Francisco, California, United States, 94143
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8064
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Children's Health
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis Children's Hospital
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
    • Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75247
    • Utah
      • Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 2 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Admission to the pediatric ICU with a confirmed diagnosis of RSV infection. RSV infection is based on a positive nasal swab for RSV fluorescent antibody or via multiplex assay or culture;
  • Requiring intensive respiratory support defined as either mechanical ventilation or NIV (BiPAP or CPAP) or HFNC (at >1 L/kg/min of flow
  • Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;
  • Onset of RSV-related symptoms must be less than 5 days
  • Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth.

Exclusion criteria:

  • AZM use within 7 days of ICU admission;
  • Contraindication to AZM use including known hypersensitivity to AZM, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL or ALT ≥ 10 times the upper limits of normal);
  • Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms);
  • Intensive respiratory support greater than 48 hours prior to ICU admission;
  • Chronic ventilation or supplemental oxygen need at home;
  • Immunosuppressive conditions such as those post heart or hematopoietic stem cell transplant or receiving chemotherapy and chronic steroids;
  • History of pyloric stenosis;
  • AZM is deemed necessary for clinical treatment (for instance, if patient has pertussis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Other: Control Group
Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
Active Comparator: AZM 20mg/kg Treatment Group
Drug: AZM Group
AZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospitalization
Time Frame: At discharge (Approximately 2 weeks)
Duration of hospitalization in days for enrolled subjects
At discharge (Approximately 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of oxygenation
Time Frame: At discharge (Approximately 1 week)
Duration of oxygenation in days for enrolled subject
At discharge (Approximately 1 week)
Length of ICU stay
Time Frame: At ICU discharge (Approximately 1 week)
Duration of ICU stay in days for enrolled subjects
At ICU discharge (Approximately 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Michele Kong, MD, The University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300007862
  • 1R01HD105678-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To be determined.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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