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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
370
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.
The University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of California San Francisco
Length of Hospitalization
Duration of hospitalization in days for enrolled subjects
Time frame: At discharge (Approximately 2 weeks)
Duration of oxygenation
Duration of oxygenation in days for enrolled subject
Time frame: At discharge (Approximately 1 week)
Length of ICU stay
Duration of ICU stay in days for enrolled subjects
Time frame: At ICU discharge (Approximately 1 week)
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San Francisco, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
RECRUITINGChildren's National Hospital
Washington D.C., District of Columbia, United States
RECRUITINGAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGRiley Children's Health
Indianapolis, Indiana, United States
RECRUITINGSt. Louis Children's Hospital
St Louis, Missouri, United States
RECRUITINGUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGRainbow Babies and Children's Hospital
Cleveland, Ohio, United States
RECRUITING...and 5 more locations