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
56 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
Researchers are investigating the use of Azithromycin (AZM) to treat children with severe Respiratory Syncytial Virus (RSV)-induced respiratory failure. This randomized, double-blinded, placebo-controlled Phase III trial aims to see if AZM can reduce illness severity by affecting a specific biological pathway called matrix metalloproteinase (MMP)-9. The study focuses on pediatric patients who need intensive care and respiratory support due to RSV lung disease. Participants will be randomly assigned to receive either AZM or a placebo. Those in the AZM group will get 20 mg/kg of the drug intravenously once daily for three days. The control group will receive saline intravenously on the same schedule. Patients will be recruited during their acute hospitalization and admission to the intensive care unit at selected pediatric hospitals. Throughout the study, researchers will monitor participants closely, including measuring how long they stay in the hospital and intensive care unit, as well as how long they require oxygen support. These assessments will occur around one to two weeks after treatment starts. The study will help determine if AZM can improve recovery times in children facing severe RSV infections, with safety and treatment effects carefully observed during the trial period.
CONDITIONS
Brief 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
- Requires intensive respiratory support such as mechanical ventilation, BiPAP, CPAP, or high-flow nasal cannula at over 1 L/kg/min
- Enrollment within 48 hours of ICU admission and starting intensive respiratory support
- Symptoms of RSV infection started less than 5 days before enrollment
- Age from birth (neonates discharged home after birth) up to 2 years old
You will not qualify if you...
- Use of Azithromycin within 7 days before ICU admission
- Known allergy or hypersensitivity to Azithromycin, erythromycin, macrolides, or ketolides
- Significant liver impairment with high bilirubin or ALT levels
- Known heart disease, arrhythmia, or prolonged QTc interval (450 ms or more)
- Receiving intensive respiratory support for more than 48 hours before ICU admission
- Chronic ventilation or oxygen use at home
- Immunosuppressive conditions such as post-transplant, chemotherapy, or chronic steroid use
- History of pyloric stenosis
- Clinical need for Azithromycin treatment (e.g., pertussis infection)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during ICU admission
Duration - 3 days
Participants receive intravenous azithromycin or placebo daily for 3 days while in the ICU.
Daily intravenous administration for 3 days
Duration - Up to approximately 2 weeks
Participants are monitored until hospital discharge, including ICU stay and oxygenation duration.
Visits and assessments during hospital stay until discharge
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
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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