Status:
TERMINATED
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
University of Utah
Emory University
Conditions:
Asthma
Wheezing
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 Emergen...
Detailed Description
This Phase III trial is designed as a parallel group, placebo-controlled, double-blind, randomized, multi-center evaluation of AZ for the treatment of acute wheezing episodes. The study will recruit e...
Eligibility Criteria
Inclusion
- 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
- 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 invasive 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 of the parent or guardian to speak English or Spanish.
- Positive PCR or antigen test for COVID-19 from hospital/doctor's office/testing center within the past 30 days.
Key Trial Info
Start Date :
September 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2025
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT04669288
Start Date
September 22 2021
End Date
January 8 2025
Last Update
March 4 2025
Active Locations (8)
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1
Children's Healthcare of Atlanta, Emory University
Atlanta, Georgia, United States, 30322
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
Children's Hospital of New York Medical Center
New York, New York, United States, 10032
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229