Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis (APW-RSV)
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.
In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in:
- Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization.
- A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis|
- IL-8 Concentrations [ Time Frame: Day 8 ]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.
- Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes [ Time Frame: 3-52 weeks following randomization ]Clinical outcome: The difference in the proportion of participants who experience subsequent recurrent (≥2) wheezing episodes among infants treated with azithromycin and those treated with placebo.
- Concentrations of IL-8 in Nasal Lavage on Day 15 [ Time Frame: Day 15 ]
- Rates of Drug Related GI Side Effects. [ Time Frame: One month from randomization ]
- Likelihood to Develop 3 or More Wheezing Episodes [ Time Frame: Week 3-52 ]Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis
- Respiratory Symptoms Following RSV Bronchiolitis [ Time Frame: 3-52 weeks following randomization ]Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)
- Number of Children Who Were Prescribed Inhaled Corticosteroids [ Time Frame: 3-52 weeks following randomization ]
- Proportion of Participants With a Physician Diagnosis of Asthma [ Time Frame: Week 3-52 ]The proportion of participants with a physician diagnosis of asthma
|Study Start Date:||December 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Azithromycin
Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Placebo Comparator: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486758
|United States, Missouri|
|Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Avraham Beigelman, MD, MSCI||Washington University School of Medicine|