Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II (NCT02911935) | Clinical Trial Compass
CompletedPhase 2/3
Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II
United States200 participantsStarted 2016-11
Plain-language summary
The main objective of the APW-RSV II clinical trial is to evaluate if the addition of azithromycin to routine bronchiolitis care, among infants hospitalized with RSV bronchiolitis, reduces the occurrence of recurrent wheeze during the preschool years.
Who can participate
Age range1 Month ā 18 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 1-18 months.
* Hospitalization for the first episode of RSV bronchiolitis.
* Confirmed RSV infection by positive nasal swab results (PCR assay and/or direct antigen detection).
* 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)28.
* Duration of respiratory symptoms from onset of symptoms of the current illness to admission is 120 hours (5 days) or less.
* Randomization can be performed within 168 hours (7 days) from onset of symptoms.
* 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 and/or food allergy 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 (before the current episode) treatment with albuterol.
* History of previous treatment with corticosteroid (systemic or inhaled) for respiratory issues.
* Treatment (past or present) with monā¦
What they're measuring
1
Number of Participants Who Experienced the Occurrence of a Third Episode of Post-RSV Wheezing (Recurrent Wheeze)