AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department (AZ-SWED)
Asthma, Wheezing
About this trial
This is an interventional treatment trial for Asthma focused on measuring Wheezing Lower Respiratory Illness (WLRI)
Eligibility 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.
Sites / Locations
- Children's Healthcare of Atlanta, Emory UniversityRecruiting
- Boston Children's HospitalRecruiting
- Children's Hospital of New York Medical CenterRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- University of Pittsburgh Medical CenterRecruiting
- The Medical College of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Treatment - Active
Treatment - Placebo
Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered the active drug per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.
Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered placebo per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.