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TerminatedPhase 3

AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department

Key facts

Who runs it
University of Arizona
Where
Atlanta, Boston, Cincinnati, Dallas, Milwaukee, New York, Philadelphia, and Pittsburgh, United StatesSee the 8 sites
Trial code
Status
Terminated
Phase
Phase 3
People taking part
840 people enrolled
Started
22 Nov 2021
Ended
8 Jan 2025
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Azithromycin
  • Placebo
Record updated
23 June 2026
Why it stopped
The AZ-SWED trial was stopped by the National Heart, Lung, and Blood Institute (NHLBI) due to futility

Who can take part

Age
18 months to 60 months
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current or previous use of systemic antibiotics within the last 2 weeks
  • Current or previous use of a steroid for wheezing within the last 2 weeks
  • Received oxygen for more than 5 days in the neonatal period, or received invasive mechanical ventilation
  • Participation in the evaluation of a drug or medical device currently or within the last 30 days
  • Previous enrollment into this trial
  • Presence of acute infection that requires systemic antibiotics, as determined by the physician
  • A known systemic illness (other than allergy) including but not limited to:; Recurrent seizures; Gastroesophageal reflux (GER) requiring medical treatment; Major congenital anomalies; Physical and intellectual delay; Cerebral palsy; A history of chest surgery; Tuberculosis or other chronic infections; Primary or secondary immunodeficiency; Gastrointestinal malformation or disease; Cardiac disorder (except for a hemodynamically insignificant atrial septal defect (ASD), ventricular septal defect (VSD) or benign heart murmur)
  • Significant developmental delay / failure to thrive, defined as a child plotting less than 3rd percentile
  • Any chronic lung disease
  • Known sensitivity or allergy to AZ
  • Positive PCR or antigen test for COVID-19 from hospital/doctor's office/testing center within the past 30 days
  • Born at less than 36 weeks estimated gestational age
  • Suspected foreign body induced aspiration during the last 2 weeks
  • The study intervention poses undue risk to patient in the opinion of the treating physician
  • Inability of the parent or guardian to speak English or Spanish

Where in United States

  • Children's Healthcare of Atlanta, Emory UniversityAtlanta, United StatesNo longer taking part
  • Boston Children's HospitalBoston, United StatesNo longer taking part
  • Cincinnati Children's Hospital Medical CenterCincinnati, United StatesNo longer taking part
  • University of Texas Southwestern Medical CenterDallas, United StatesNo longer taking part
  • The Medical College of WisconsinMilwaukee, United StatesNo longer taking part
  • Children's Hospital of New York Medical CenterNew York, United StatesNo longer taking part
  • The Children's Hospital of Philadelphia (CHOP)Philadelphia, United StatesNo longer taking part
  • University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Treatment - ActiveExisting treatment, for comparison

    Eligible participants were randomly assigned to the Azithromycin arm (1:1)

    Treatment: Azithromycin

  • Treatment - PlaceboPlacebo, for comparison

    Eligible patients were randomly assigned to the placebo arm, per the randomization schedule (1:1).

    Treatment: Placebo

Results explained

A paper that names this trial, explained in plain words.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department (AZ-SWED)
Publications
Record updated
23 June 2026