drugset / Trial / NCT01486758
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 5 mg/kg | Oral |