CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
Azithromycin 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01486758
NCT01486758Phase 2Completed
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Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis

Washington University School of Medicine·interventional·Posted Dec 6, 2011·Updated Jun 14, 2017

In Brief

A Phase 2 clinical trial evaluating Azithromycin and Placebo for RSV Bronchiolitis. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRSV Bronchiolitis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2011
Enrollment StartDec 1, 2011
Primary CompletionApr 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.6 years ago

Interventions

Azithromycindrug

Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.

Placebodrug