Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-01-28, after 2022-06-01 start.
Reason given by the sponsor: “enrollment”
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 2024-01-28. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientiiregimenspatientscombination
Phrases that lowered it: and safetyrandomizedindexefficacy andsafety of -
Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports with a death: 26.9% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 8.3% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Blinding: single (lowers risk) · Design
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Drug's FAERS reports marked serious: 94.5% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 85 (lowers risk) · Who can join
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Drug's FAERS reports before start: 10122 (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Number of arms: 2 (raises risk) · Design
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 85 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 36 (typical: 32)
- Sponsor's past termination rate
- 8.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 10122 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1276 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- avibactam, avibactam ceftazidime, ceftazidime, colistin
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
- A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE) NCT01970371 · started 2014 · scored riskier than 65% of active trials completed
- P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales NCT05905055 · started 2023 · scored riskier than 36% of active trials completed
- Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens NCT01644643 · started 2013 · scored riskier than 78% of active trials completed
- Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins NCT04478721 · started 2020 · scored riskier than 84% of active trials completed
- Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013) NCT02452047 · started 2015 · scored riskier than 44% 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.