NCT01486758

Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis

Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Month – 18 Months
• Healthy volunteers: Not accepted

Summary

This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial Virus (RSV) bronchiolitis. HYPOTHESES In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in: 1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization. 2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.

Conditions

• RSV Bronchiolitis

Interventions

Type	Name	Description
DRUG	Azithromycin	Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
DRUG	Placebo

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2011-12-06
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States