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

Completed · Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus

In brief

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).

Key facts

Study ID

NCT02707523

Run by

University of Alabama at Birmingham

People needed

48

Starts

2016-01-01

Expected to finish

2020-06-20

Last updated by the study team

2020-07-22

Who can join

Age: any, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UAB — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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