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

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Presence of acute infection that requires systemic antibiotics, as determined by the physician.

• 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.

• Suspected foreign body induced aspiration during the last 2 weeks.

• 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)

• Born at less than 36 weeks estimated gestational age.

• Received oxygen for more than 5 days in the neonatal period, or received mechanical ventilation.

• Significant developmental delay / failure to thrive, defined as a child plotting less than 3rd percentile.

• Any chronic lung disease.

• The study intervention poses undue risk to patient in the opinion of the treating physician

• Known sensitivity or allergy to AZ.

• Participation in the evaluation of a drug or medical device currently or within the last 30 days.

• Previous enrollment into this trial.

• Inability to speak English or Spanish.