Azithromycin for Wheezing in Preschoolers
(AZ-SWED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if giving preschool children with severe wheezing a medicine called Azithromycin can reduce their symptoms. The study includes children with and without certain bacteria in their noses. The goal is to see if the medicine helps by reducing bacterial infections or improving wheezing overall. Azithromycin has been studied for its potential to reduce severe asthma symptoms, with mixed results in different patient groups.
Who Is on the Research Team?
Charlie Casper, PhD
Principal Investigator
University of Utah
Kurt Denninghoff, MD
Principal Investigator
University of Arizona
Fernando D Martinez, MD
Principal Investigator
University of Arizona
Are You a Good Fit for This Trial?
This trial is for preschool children aged 18 months to under 60 months who are experiencing a severe wheezing episode and have been assessed at the emergency department. They must not have used antibiotics or steroids for wheezing in the past two weeks, among other health criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Azithromycin or placebo for 5 days, with daily electronic transmission of the Asthma Flare-up Diary for Young Children (ADYC) and daily contact for compliance and complications assessment
Follow-up
A subset of participants will have follow-up visits to assess antibiotic resistance and treatment response related changes in the airway microbiome
What Are the Treatments Tested in This Trial?
Interventions
- Azithromycin
- Placebo
Azithromycin is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arizona
Lead Sponsor
University of Utah
Collaborator
Emory University
Collaborator
Morgan Stanley Children's Hospital
Collaborator
University of Pittsburgh
Collaborator
Children's Hospital and Health System Foundation, Wisconsin
Collaborator
Children's Hospital of Philadelphia
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
Boston Children's Hospital
Collaborator