Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children

Inclusion criteria:

• Admission to the pediatric ICU with a confirmed diagnosis of RSV infection. RSVinfection is based on a positive nasal swab for RSV fluorescent antibody or viamultiplex assay or culture;

• Requiring intensive respiratory support defined as either mechanical ventilation orNIV (BiPAP or CPAP) or HFNC (at >1 L/kg/min of flow

• Enrollment into the study within 48 hours of ICU admission and placement onintensive 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 beendischarged home from the hospital after their birth.

Exclusion criteria:

• 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 QTinterval corrected for heart rate (QTc) ≥ 450 milisecond (ms);

• Intensive respiratory support greater than 48 hours prior to ICU admission;

• Chronic ventilation or supplemental oxygen need at home;

• Immunosuppressive conditions such as those post heart or hematopoietic stem celltransplant or receiving chemotherapy and chronic steroids;

• History of pyloric stenosis;

• AZM is deemed necessary for clinical treatment (for instance, if patient haspertussis).