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AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
Sponsor: University of Arizona
Summary
AZ-SWED is a parallel group, double blind, placebo control efficacy clinical trial with two separate hypotheses. The trial compared the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated with either once daily oral Azithromycin (12 mg/kg/day for 5 days) or placebo. The AZ-SWED researchers made separate comparisons in children in whom specific pathogenic bacteria isolated from nasopharyngeal swabs, and in those in whom they were not isolated. The primary outcome was the Asthma Flare-up Diary for Young Children (ADYC), a validated instrument that caregivers will transmit electronically daily after discharge from the ED. Families were contacted daily during the five-day treatment to collect the ADYC, and to assess compliance and complications. A randomly chosen subset of enrolled children participated in two follow-up visits 5-8 days and 14-21 days after visit 1 to assess development of resistance to study drug and treatment response related changes in the airway microbiome.
Official title: AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department (AZ-SWED)
Key Details
Gender
All
Age Range
18 Months - 60 Months
Study Type
INTERVENTIONAL
Enrollment
840
Start Date
2021-11-22
Completion Date
2025-01-08
Last Updated
2026-06-23
Healthy Volunteers
No
Interventions
Azithromycin
oral azithromycin (12 mg/kg per day for 5 days) Local investigational drug pharmacies were provided with active study medication (azithromycin) from a central pharmacy. Azithromycin was reconstituted with water at the local pharmacy, and resembled placebo with regards to appearance, flavor, consistency and packaging.
Placebo
oral placebo (12 mg/kg per day for 5 days) Local investigational drug pharmacies were provided with placebo from a central pharmacy. Placebo was reconstituted with water at the local pharmacy, and resembled azithromycin with regards to appearance, flavor, consistency and packaging.
Locations (8)
Children's Healthcare of Atlanta, Emory University
Atlanta, Georgia, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Hospital of New York Medical Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States