Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Start Date
2/27/2022
Completion Date
7/31/2028
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.
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.
Eligibility Criteria
Age Range: No minimum to 2 years
Interventions
AZM Group
Control Group
Conditions
Locations
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