Wheezing Treatment with Azithromycin Therapy: The AZ-SWED Study – Phase III

Azithromycin Therapy in Preschoolers with a Severe Wheezing Episode Diagnosed at the Emergency Department

Protocol Description

The goal of this multi-center research study is to determine the effectiveness of the oral antibiotic azithromycin in treating preschoolers experiencing acute wheezing episodes.

Study Level: Phase III

Eligibility Criteria

Children, ages 18 through 59 months, being seen in the Emergency Department for an acute wheezing episode, are eligible for participation in this study.
Boys and Girls: Ages 18 months through 4 years (59 months)

Requirements

Participants will be given a physical examination that will include a cheek and nasal swab to collect biologic samples. Through randomized selection, participants will be provided a 5-day prescription of either azithromycin or a placebo. Parents/guardians will provide information about the child’s symptoms during the Emergency Department visit and will complete a daily diary about the child’s symptoms during drug therapy. The research team will follow up with the parent/guardian on day 8. Some children will be randomly selected for follow-up visits for additional examinations and testing.
Visits: 1 to 3, depending on whether participating in follow-up visits
Duration: 8 to 21 days, depending on whether participating in follow-up visits

Status: Open to Enrollment

Source(s) of Support

National Heart, Lung, and Blood Institute

Primary Investigator

Melissa Tavarez, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator
412-692-8380