Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
2 other identifiers
interventional
370
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2022
Longer than P75 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedStudy Start
First participant enrolled
February 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
February 9, 2026
February 1, 2026
5.3 years
August 24, 2021
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of Hospitalization
Duration of hospitalization in days for enrolled subjects
At discharge (Approximately 2 weeks)
Secondary Outcomes (2)
Duration of oxygenation
At discharge (Approximately 1 week)
Length of ICU stay
At ICU discharge (Approximately 1 week)
Study Arms (2)
Control Group
PLACEBO COMPARATORAZM 20mg/kg Treatment Group
ACTIVE COMPARATORInterventions
AZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California San Francisco
San Francisco, California, 94143, United States
Yale School of Medicine
New Haven, Connecticut, 06520-8064, United States
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Children's Health
Indianapolis, Indiana, 46202, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75247, United States
University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Kong, MD
The University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
August 24, 2021
First Posted
August 30, 2021
Study Start
February 27, 2022
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 31, 2028
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
To be determined.