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 groupsSponsors 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