Status:
COMPLETED
Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Respiratory Syncytial Virus
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE2
Brief 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...
Detailed Description
Eligible participants include all children admitted to the PICU at Children's of Alabama with a diagnosis of RSV infection and requiring positive pressure ventilation, invasive or noninvasive, includi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02707523
Start Date
January 1 2016
End Date
June 20 2020
Last Update
July 22 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UAB
Birmingham, Alabama, United States, 35233