Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II

Who is this study for? Patients with Respiratory Syncytial Virus, Bronchiolitis
What treatments are being studied? Oral Azithromycin
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1
Healthy Volunteers: f
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• 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.

Locations
United States
Missouri
Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital
Saint Louis
Time Frame
Start Date: 2016-11
Completion Date: 2021-04
Participants
Target number of participants: 200
Treatments
Active_comparator: Oral azithromycin
Oral Azithromycin
Placebo_comparator: Placebo
Oral Placebo
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov