NCT02911935

Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Month – 18 Months
• Healthy volunteers: Not accepted

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.

Detailed description

The APW-RSV II clinical trial is a double blind, placebo-controlled, parallel-group, randomized trial, including otherwise healthy 188 participants, ages 1-18 months, who are hospitalized due to RSV bronchiolitis. The study includes active treatment phase with azithromycin or placebo for 2 weeks, and an observational phase for up to 48 months. 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 (RW) during the preschool years. Study participants will be enrolled during 3 consecutive RSV seasons beginning in Fall 2016. Study participants will be randomized to receive PO azithromycin 10 mg/kg/day for 7 days followed by 5mg/kg/day for additional 7 days, or matched placebo. The primary clinical outcome is the time to the occurrence of a third episode of wheezing. The duration of follow up is 18-48 months, which is determined based on the year in which the participants is recruited: first year recruits will be followed for up to 48 months, while the 3rd year recruits will be followed for at least 18 months.

Conditions

• Respiratory Syncytial Virus, Bronchiolitis

Interventions

Type	Name	Description
DRUG	Oral azithromycin	Oral azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days
DRUG	Placebo	Placebo suspension

Timeline

• Start date: 2016-11-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2016-09-22
• Last updated: 2022-06-07
• Results posted: 2022-06-07

Locations

1 site across 1 country: United States