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NCT01486758 · ClinicalTrials.gov registry record · Phase 2
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01486758: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT01486758 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01486758, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.
Interventions
- DRUG Placebo
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01486758 record still lists
NCT01486758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01486758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01486758 about?
NCT01486758 is a clinical study titled "Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis". 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...
What is the current status of trial NCT01486758?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2011-12. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01486758?
The interventions under investigation include: Placebo (DRUG), Azithromycin (DRUG).
Who is sponsoring clinical trial NCT01486758?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01486758's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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