AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (84 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2025-01-08, after 2021-11-22 start.
Reason given by the sponsor: “efficacy”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-01-08. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Sponsor's past termination rate: 17.0% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Collaborators: 9 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: or equalequal toadmissionacutegreater than
Phrases that lowered it: asthmadaysrespiratorydrug14 -
Phase: 3 (lowers risk) · Design
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Blinding: triple (raises risk) · Design
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Drug's FAERS reports with a death: 9.1% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 47 (lowers risk) · Sponsor's track record
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Minimum age: 1.5 (lowers risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: 74.3% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Disease area, respiratory: Yes (raises risk) · Disease area
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Sponsor's past trials: 171 (lowers risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 9903 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 69531 (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 9 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 1.5 (typical: 18)
- Maximum age
- 5 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 171 (typical: 32)
- Sponsor's past termination rate
- 17.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 47 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 69531 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9903 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, immunology
- Drugs matched to FDA substances
- azithromycin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids. NCT01272635 · started 2011 · scored riskier than 33% of active trials completed
- Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II NCT02911935 · started 2016 · scored riskier than 44% of active trials completed
- CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) NCT00675584 · started 2008 · scored riskier than 22% of active trials completed
- Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis NCT01486758 · started 2011 · scored riskier than 46% of active trials completed
- Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study NCT03567473 · started 2018 · scored riskier than 49% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.