drugset / Trial / NCT01486758

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

NCT01486758

Phase 2 Completed 40 enrolled Washington University School of Medicine
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2011-12
Primary completion
2014-04
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azithromycin Small molecule 5 mg/kg Oral