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TERMINATED
NCT04669288
PHASE3

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

Sponsor: University of Arizona

View on ClinicalTrials.gov

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

Conditions

Interventions

DRUG

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.

DRUG

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