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Clinical trialNCT04669288TerminatedPhase 3Interventional

AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department

SponsorUniversity of ArizonaEnrollment840AsthmaWheezing
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
22 Nov 2021
Primary completion
10 Dec 2024
Completion
8 Jan 2025
Last update posted
23 Jun 2026
Registered enrollment
840
Registry id
NCT04669288

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.