Population Pharmacokinetic (PK) Study of Multiple Doses of Cubicin® (Daptomycin) 10 mg/kg in Critical Care Patients Having Bacteremia, Endocarditis or Skin Soft Tissue Infections Due to Gram Positive Bacteria With Various Degrees of Renal Failure
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (169 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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. 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: 40% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: effectpharmacokineticspkof multiplerenal
Phrases that lowered it: patientswomenupperlimittissue -
Primary purpose: not given (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Blinding: not given (lowers risk) · Design
-
Maximum age: 85 (raises risk) · Who can join
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Keywords listed: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 90.5% (lowers risk) · Drug's FDA history
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
- 1 (typical: 2)
- Allocation
- not given (typical: randomized)
- Design
- not given (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- not given (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- 10 (typical: 32)
- Sponsor's past termination rate
- 40% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (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
- 640 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 146 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- daptomycin
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
- Optimization Dose Study on Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients NCT02408185 · started 2011 · scored riskier than 41% of active trials completed
- Population Pharmacokinetic (PK) Study of Zinforo (Ceftaroline) in Critical Care Patients With Early-onset Pneumonia and Normal or Augmented Renal Clearance NCT03025841 · started 2016 · scored riskier than 46% of active trials completed
- A Pharmacokinetic-pharmacodynamic Dose Comparison Study of 8 mg/kg of Inhaled or Parenteral Gentamicin in 12 Mechanically Ventilated Critically Ill Patients Treated for Ventilator-associated Pneumonia NCT02515448 · started 2015 · scored riskier than 70% of active trials completed
- Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance NCT04147221 · started 2020 · scored riskier than 52% of active trials completed
- PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections NCT00679835 · started 2008 · scored riskier than 36% 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.