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

Summary

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.

Timeline

Start

2021-11-22

Primary completion

2024-12-10

Completion

2025-01-08

Publications

• Denninghoff KR, Casper TC, Zorc JJ, Ruddy RM, Satola S, Wendt WJ, Morris CR, Tavarez MM, Lipshaw MJ, Kwok MY, Nesiama JO, Nelson KA, Webb M, Martinez FD; PECARN AZ-SWED Trial Study Group. Azithromycin for Preschoolers with Wheezing in the Emergency Department. N Engl J Med. 2026 May 18:10.1056/NEJMoa2516505. doi: 10.1056/NEJMoa2516505. Online ahead of print.

Drugs

Indications