NCT01486758CompletedPhase 2
Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis
Washington University School of Medicine1 site in 1 country40 target enrollmentStarted: December 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- IL-8 Concentrations
Study Overview
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:
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Month to 18 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 1-18 months.
- •Hospitalization for the first episode of RSV bronchiolitis:
- •Confirmed RSV infection by positive nasal swab results (viral culture and/or direct antigen detection) from the SLCH virology lab; AND
- •At least two of the following symptoms/signs of bronchiolitis: respiratory rate greater than 40 breaths/minute; cough; wheezing; audible rales, crackles, and/or rhonchi; paradoxical chest movements (retractions).
- •Duration of respiratory symptoms from initiation of symptoms to admission is 5 days or less. Time of admission will define by the time the child was seen in the ED for the visit that led to hospitalization.
- •Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor).
- •Willingness to provide informed consent by the child's parent or guardian
Exclusion Criteria
- •Prematurity (gestational age < 36 weeks).
- •Presence or history of other significant disease (CNS, lung, cardiac, renal, GI, hepatic disease, hematologic, endocrine or immune disease). Children with atopic dermatitis will not be excluded from the study.
- •Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
- •The child has significant developmental delay/failure to thrive, defined as weight < 3% for age and gender.
- •History of previous (before the current episode) wheeze or previous treatment with albuterol.
- •Treatment (past of present) with corticosteroid (systemic or inhaled) and/or montelukast.
- •Treatment with any antibiotics in the past 2 weeks.
- •Treatment with Macrolide antibiotic (Azithromycin, clarithromycin or erythromycin) with the past 4 weeks.
- •Current treatment with any daily medication (other then albuterol, vitamins or nutritional supplements).
- •Participation in another clinical trial.
- •Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.
- •Contraindication of use of azithromycin or any other macrolide antibiotics.
Arms & Interventions
Azithromycin
Active Comparator
Oral azithromycin
Intervention: Azithromycin (Drug)
Placebo
Placebo Comparator
Oral Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Concentrations of IL-8 in Nasal Lavage on Day 15(Day 15)
- Respiratory Symptoms Following RSV Bronchiolitis(3-52 weeks following randomization)
- Rates of Drug Related GI Side Effects.(One month from randomization)
- Likelihood to Develop 3 or More Wheezing Episodes(Week 3-52)
- Number of Children Who Were Prescribed Inhaled Corticosteroids(3-52 weeks following randomization)
- Proportion of Participants With a Physician Diagnosis of Asthma(Week 3-52)
Investigators
Avraham Beigelman
Assistant Professor of Pediatrics
Washington University School of Medicine
Study Sites (1)
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