AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department (AZ-SWED)

Status: Terminated
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

AZ-SWED is a parallel group, double blind, placebo control efficacy clinical trial with two separate hypotheses. The trial will compare 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 will make separate comparisons in children in whom specific pathogenic bacteria are isolated from nasopharyngeal swabs, and in those in whom they are not isolated. The primary outcome will be the Asthma Flare-up Diary for Young Children (ADYC), a validated instrument that caregivers will transmit electronically daily after discharge from the ED. Families will be contacted daily during the five-day treatment to collect the ADYC, and to assess compliance and complications. A randomly chosen subset of enrolled children will participate 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 5
Healthy Volunteers: f
View:

• Age 18 months to \<60 months.

• The presence of expiratory wheezing as ascertained by a physician or nurse practitioner at admission to the ED.

• A Pediatric Respiratory Assessment Measurement (PRAM) score of greater than or equal to 4 at any time during the ED admission.

Locations
United States
Georgia
Children's Healthcare of Atlanta, Emory University
Atlanta
Massachusetts
Boston Children's Hospital
Boston
New York
Children's Hospital of New York Medical Center
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Pennsylvania
The Children's Hospital of Philadelphia (CHOP)
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
Texas
University of Texas Southwestern Medical Center
Dallas
Wisconsin
The Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2021-09-22
Completion Date: 2025-01-08
Participants
Target number of participants: 840
Treatments
Active_comparator: Treatment - Active
Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered the active drug per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.
Placebo_comparator: Treatment - Placebo
Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered placebo per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.
Related Therapeutic Areas
Sponsors
Collaborators: Emory University, Boston Children's Hospital, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, University of Pittsburgh, University of Utah, Children's Hospital and Health System Foundation, Wisconsin, Morgan Stanley Children's Hospital
Leads: University of Arizona

This content was sourced from clinicaltrials.gov