Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 12:27 PM
Study NCT ID:
NCT01486758
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2011-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APW-RSV
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ICTS, Washington University | OTHER_GRANT | CTSA402 | View |