AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
Status:
Recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Arizona
Collaborators:
Boston Children's Hospital Children's Hospital and Health System Foundation, Wisconsin Children's Hospital Medical Center, Cincinnati Children's Hospital of Philadelphia Emory University Morgan Stanley Children's Hospital University of Pittsburgh University of Utah