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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01486758
Study type Interventional
Source Washington University School of Medicine
Contact
Status Completed
Phase Phase 2
Start date December 2011
Completion date May 2014

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04144816 - Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
Active, not recruiting NCT03627572 - RESCEU Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Europe in Infants
Terminated NCT00361452 - Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study Phase 4