Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04669288 · ClinicalTrials.gov registry record · Phase 3
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
A Phase 3 study, sponsored by University of Arizona.
- Terminated
- Registry status
- Phase 3
- Development phase
- 840
- Enrollment target
NCT04669288 is a Phase 3 study that was terminated before completion, run by University of Arizona. The registered enrollment target is 840 participants.
The verdict
NCT04669288, a Phase 3 study, was terminated before completion, sponsored by University of Arizona.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 840 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 840 participants |
| Start Date | 2021-11-22 |
| Est. Completion | 2025-01-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04669288
The ClinicalTrials.gov registry entry for NCT04669288 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 840 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04669288 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04669288 about?
NCT04669288 is a clinical study titled "AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department". 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 Azithr...
What is the current status of trial NCT04669288?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 840 participants. The study started on 2021-11-22. Estimated completion is 2025-01-08.
What interventions are being tested in trial NCT04669288?
The interventions under investigation include: Placebo (DRUG), Azithromycin (DRUG).
Who is sponsoring clinical trial NCT04669288?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.