AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency De… (NCT04669288) | Clinical Trial Compass
TerminatedPhase 3
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
Stopped: The AZ-SWED trial was stopped by the National Heart, Lung, and Blood Institute (NHLBI) due to futility
United States840 participantsStarted 2021-11-22
Plain-language 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.
Who can participate
Age range
18 Months – 60 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 invasive mechanical ventilation.
* Significant developmental delay / failure to thrive, defined as a child plotting less than 3rd percentile.
* Any chronic lung disease.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.