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 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.

Conditions

• Asthma
• Wheezing

Interventions

DRUG

Azithromycin

oral azithromycin (12 mg/kg per day for 5 days) Local investigational drug pharmacies will be provided with active study medication (azithromycin) from a central pharmacy. Azithromycin will be reconstituted with water at the local pharmacy, and will resemble placebo with regards to appearance, flavor, consistency and packaging.

DRUG

Placebo

oral placebo (12 mg/kg per day for 5 days) Local investigational drug pharmacies will be provided with placebo from a central pharmacy. Placebo will be reconstituted with water at the local pharmacy, and will resemble azithromycin with regards to appearance, flavor, consistency and packaging.

Sponsors & Collaborators

• University of Utah

  collaborator OTHER

• Emory University

  collaborator OTHER

• Morgan Stanley Children's Hospital

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Children's Hospital and Health System Foundation, Wisconsin

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• University of Arizona

  lead OTHER

Principal Investigators

• Fernando D Martinez, MD · University of Arizona

• Kurt Denninghoff, MD · University of Arizona

• Charlie Casper, PhD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Months

Max Age

60 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-22

Primary Completion

2024-12-10

Completion

2025-01-08

FDA Drug

Yes

Countries

• United States

Study Locations