840 Participants Needed

Azithromycin for Wheezing in Preschoolers

(AZ-SWED Trial)

Recruiting at 7 trial locations
LF
FD
RR
Overseen ByRichard Ruddy, MD
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Arizona
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

CC

Charlie Casper, PhD

Principal Investigator

University of Utah

KD

Kurt Denninghoff, MD

Principal Investigator

University of Arizona

FD

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

Your Pediatric Respiratory Assessment Measurement (PRAM) score was 4 or higher at any point during the emergency room visit.
I am between 18 and 59 months old.
A doctor or nurse heard wheezing when I breathed out during my ED visit.

Exclusion Criteria

I have taken antibiotics in the last 2 weeks.
I have used steroids for wheezing in the last 2 weeks.
I may have inhaled a foreign object in the last 2 weeks.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Day 0
1 visit (in-person)

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

5 days
Home-based administration

Follow-up

A subset of participants will have follow-up visits to assess antibiotic resistance and treatment response related changes in the airway microbiome

21 days
2 visits (in-person) on Day 5-8 and Day 14-21

What Are the Treatments Tested in This Trial?

Interventions

  • Azithromycin
  • Placebo
Trial Overview The AZ-SWED study tests if Azithromycin (12 mg/kg/day for 5 days) helps improve severe wheezing episodes in young children compared to a placebo. The effect is measured using daily caregiver reports and follow-up visits, with some focus on bacterial presence.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Treatment - ActiveActive Control1 Intervention
Group II: Treatment - PlaceboPlacebo Group1 Intervention

Azithromycin is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Azithromycin for:
🇺🇸
Approved in United States as Azithromycin for:
🇨🇦
Approved in Canada as Azithromycin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials
545
Recruited
161,000+

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

Morgan Stanley Children's Hospital

Collaborator

Trials
10
Recruited
5,012,000+

University of Pittsburgh

Collaborator

Trials
1,820
Recruited
16,360,000+

Children's Hospital and Health System Foundation, Wisconsin

Collaborator

Trials
56
Recruited
93,300+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials
844
Recruited
6,566,000+

Boston Children's Hospital

Collaborator

Trials
801
Recruited
5,584,000+
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