Actively Recruiting
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Led by University of Alabama at Birmingham · Updated on 2026-02-09
370
Participants Needed
15
Research Sites
335 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admission to the pediatric ICU with confirmed RSV infection by nasal swab or culture
- Need for intensive respiratory support including mechanical ventilation, BiPAP, CPAP, or high-flow nasal cannula at >1 L/kg/min
- Enrollment within 48 hours of ICU admission and start of intensive respiratory support
- Onset of RSV symptoms less than 5 days before enrollment
- Age from newborn (discharged home if less than 1 week old) up to 2 years
You will not qualify if you...
- Use of Azithromycin within 7 days before ICU admission
- Known allergy or contraindication to Azithromycin, erythromycin, other macrolides, or ketolides
- Significant liver problems with high bilirubin or ALT levels
- Known heart disease, arrhythmia, or QTc interval ≥ 450 ms on ECG
- Intensive respiratory support for more than 48 hours before ICU admission
- Chronic ventilation or oxygen need at home
- Immunosuppressive conditions including post-transplant, chemotherapy, or chronic steroids
- History of pyloric stenosis
- Clinical need for Azithromycin (e.g., pertussis infection)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Yale School of Medicine
New Haven, Connecticut, United States, 06520-8064
Actively Recruiting
4
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Riley Children's Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
8
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
9
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
10
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
11
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
12
Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
13
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75247
Actively Recruiting
15
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
M
Michele Kong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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