Trial · NCT04669288
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
NCT04669288, Phase 3, Terminated, University of Arizona
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department. Trials, record NCT04669288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04669288
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
- NCT number
- NCT04669288
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 840 participants, actual
- Lead sponsor
- University of Arizona
- Conditions
- Asthma, Wheezing
- Interventions
- Azithromycin, Placebo
- First posted
- 2020-12-16
- Last updated
- 2026-06-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ADYC (Median, IQR) | 5 day course of azithromycin | The Asthma Flare-up Diary for Young Children (ADYC) is a validated instrument that consists of a 17-item questionnaire scored from 1 (best) to 7 (worst). The parent or guardian of the enrolled child (up to 60 months of age) filled out the diary daily for 5 days, starting from the first day following the first dose of Azithromycin (AZ). The cumulative score at the end of 5 days was used to assess response to the intervention (e.g. time to exacerbation, acute-care visit, hospitalization and no wheeze), with a higher score indicating a worse outcome. For each of the five follow-up days, the ADYC score was calculated as the average score per question and the trial primary outcome was the sum of these ADYC scores over the five days. The range of possible primary outcome values was a ADYC score of 5 to 35. |
| Secondary | ED Length of Stay (Median, IQR) | From admission at ED to discharge from ED, up to 23 hours and 59 minutes | The continuous secondary variable of length of stay was analyzed in the same manner as the primary outcome. The measurement is the duration from arrival to ED to discharge. Subjects are separated by treatment arm and by bacterial designation. Together, the rows equal the total number of participants analyzed. |
| Secondary | Hospital Length of Stay (Median, IQR) | From hospital admission to discharge from hospital | The continuous secondary variable of length of stay was analyzed in the same manner as the primary outcome. The measurement is the duration of hospitalization from admission. Subjects are separated by treatment arm and by bacterial designation. Together, the rows equal the total number of participants analyzed. |
| Secondary | Return Visit | Within 72 hours after randomization | Visits to the ED or hospital within 72 hours of the initial visit (randomization time) are counted as a revisit outcome. This outcome was tabulated by treatment for each stratum (site and baseline severity of symptoms). The dichotomous outcome of the second ED visit or hospitalization is compared using a Mantel-Haenszel chi-square test, stratified by clinical center and baseline severity. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42149992 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG3HL147016 | 1/2: AZithromycin Therapy in Preschoolers with a Severe Wheezing Episode Diagnosed at the Emergency Department (AZ-SWED) | MARTINEZ, FERNANDO D; DENNINGHOFF, KURT R | UNIVERSITY OF ARIZONA | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2020 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04669288
GET https://conductscience.org/api/trials/v1/NCT04669288/registered