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

Who is this study for? Patients with Respiratory Syncytial Virus Infections
What treatments are being studied? Azithromycin
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 days
Maximum Age: 2
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
The University of Alabama at Birmingham
RECRUITING
Birmingham
California
University of California San Francisco
RECRUITING
San Francisco
Connecticut
Yale School of Medicine
RECRUITING
New Haven
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Indiana
Riley Children's Health
RECRUITING
Indianapolis
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Ohio
Rainbow Babies and Children's Hospital
RECRUITING
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
Oklahoma
Oklahoma Health Sciences
RECRUITING
Oklahoma City
Contact Information
Primary
Michele Kong, MD
mkong@uabmc.edu
205-638-9387
Time Frame
Start Date: 2022-02-27
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 370
Treatments
Placebo_comparator: Control Group
Active_comparator: AZM 20mg/kg Treatment Group
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov