Imipenem/Cilastatin/Relebactam PK in ECMO
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (340 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-06-30, after 2021-01-01 start.
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 2023-06-30. 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: definedlifeinjuryreceivinglimit
Phrases that lowered it: pharmacokineticsinvestigatorsafety oforalmoderate -
Primary purpose: other (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports with a death: 29.2% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Responsible party: sponsor investigator (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 94.4% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 2 (raises risk) · Sponsor's track record
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Collaborators: 1 (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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 8656 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 788 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- cilastatin, imipenem, relebactam
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
- Cefiderocol PK in Patients on ECMO NCT04995835 · started 2021 · scored riskier than 39% of active trials completed
- Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance NCT04147221 · started 2020 · scored riskier than 52% of active trials completed
- Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO) NCT01169402 · started 2010 · scored riskier than 44% of active trials completed
- A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections NCT05614895 · started 2022 · scored riskier than 36% of active trials completed
- Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation NCT01666769 · started 2013 · scored riskier than 34% 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.