University of Alabama at Birmingham
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.
Inclusion criteria: * 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 disc…
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.