Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children

• Status: Completed
• Trial end date: 2020-06-20
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (PICU). The study will include children with RSV infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation (invasive and noninvasive).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Admission to the PICU with RSV infection

• Need for positive pressure ventilation (invasive and non-invasive)

• Randomization and drug/placebo initiation within 48 hours of admission to Pediatric Intensive Care Unit

Exclusion Criteria:

• Azithromycin use within 7 days of PICU admission

• Contraindication to azithromycin use including:

• Patients with electrocardiogram QT interval corrected for heart rate (Qtc) ≥ 450 ms

• Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)

• Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug

• Cardiac arrhythmia

• History of pyloric stenosis

• Immunocompromised children (any cause)

• Current use of any medication known to cause QT prolongation