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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital
St Louis, Missouri, United States
IL-8 Concentrations
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.
Time frame: Day 8
Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes
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.
Time frame: 3-52 weeks following randomization
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
Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis
Time frame: Week 3-52
Respiratory Symptoms Following RSV Bronchiolitis
Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)
Time frame: 3-52 weeks following randomization
Number of Children Who Were Prescribed Inhaled Corticosteroids
Time frame: 3-52 weeks following randomization
Proportion of Participants With a Physician Diagnosis of Asthma
The proportion of participants with a physician diagnosis of asthma
Time frame: Week 3-52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.