Azithromycin for Wheezing in Preschoolers

(AZ-SWED Trial)

Recruiting at 7 trial locations

Overseen By Richard Ruddy, MD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Arizona

Must not be taking: Antibiotics, Steroids

Disqualifiers: Seizures, GER, Congenital anomalies, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 5 days

840 Participants Needed

Trial Summary

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.

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

Eligibility Criteria

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

Criterion: You have a long-term illness or condition that could affect your ability to participate in the study, such as seizures, developmental delays, or chronic lung disease. You have certain heart problems, were born prematurely, or have a history of certain medical procedures. You have certain allergies, are currently involved in another medical study, or cannot speak English or Spanish.

I have taken antibiotics in the last 2 weeks.

I have used steroids for wheezing in the last 2 weeks.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Treatment - Active Active Control 1 Intervention

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.

Group II: Treatment - Placebo Placebo Group 1 Intervention

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.

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

Approved in European Union as Azithromycin for:

• Respiratory tract infections
• Skin and soft tissue infections
• Sexually transmitted diseases
• Toxoplasmosis
• Malaria
• Preterm prelabor rupture of membranes

Approved in United States as Azithromycin for:

• Respiratory tract infections
• Skin and soft tissue infections
• Sexually transmitted diseases
• Toxoplasmosis
• Malaria
• Preterm prelabor rupture of membranes

Approved in Canada as Azithromycin for:

• Respiratory tract infections
• Skin and soft tissue infections
• Sexually transmitted diseases
• Toxoplasmosis
• Malaria
• Preterm prelabor rupture of membranes

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+