Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems
Model scores of the 29,894 trials active now.
Model score 14% 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 (81 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-03-07, after 2021-05-04 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 2022-03-07. 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: 4.3% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: therapyinfectioncellspatientinfusion
Phrases that lowered it: pkdrugsopen labelclinicaldrug -
Drug's FAERS reports with a death: 32.5% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 32 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 97.3% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Phase: 2/3 (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Sponsor's past trials: 163 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports before start: 19411 (raises risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 163 (typical: 32)
- Sponsor's past termination rate
- 4.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 32 (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
- 19411 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3676 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 32.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- meropenem
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
- 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
- Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae NCT02795949 · started 2016 · scored riskier than 56% 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
- 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
- Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli NCT02142751 · started 2014 · scored riskier than 78% 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.