Status:
COMPLETED
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
Lead Sponsor:
Washington University School of Medicine
Conditions:
RSV Bronchiolitis
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
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) bronch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01486758
Start Date
December 1 2011
End Date
May 1 2014
Last Update
June 14 2017
Active Locations (1)
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1
Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital
St Louis, Missouri, United States, 63110