Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-2
SponsorUniversity of Alabama at Birmingham
About this trial
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 criteria
Qualifiers
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
Disqualifiers
AZM use within 7 days of ICU admission;
Contraindication to AZM use including known hypersensitivity to AZM, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL or ALT ≥ 10 times the upper limits of normal);
Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms);
Intensive respiratory support greater than 48 hours prior to ICU admission;
Trial design
Treatments tested in this trial
- AZM Group
- Control Group
Treatment groups
370 Participants
are divided into 2 treatment groupsLocations
15Alabama
The University of Alabama at Birmingham35233, Birmingham United States
California
University of California San Francisco94143, San Francisco United States
Connecticut
Yale School of Medicine06520-8064, New Haven United States
District of Columbia
Children's National Hospital20010, Washington D.C. United States
Sponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov