Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (313 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 on 2013-12-01, after 2010-05-19 start.
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; it actually ended on 2013-12-01. 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: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: functiontreatedadequatecarepatients
Phrases that lowered it: pharmacokineticsevaluate theto evaluatebloodunit -
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 94.5% (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 20.8% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 10 (raises risk) · Sponsor's track record
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Sponsor's past trials: 13 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports before start: 3191 (raises risk) · Drug's FDA history
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Number of arms: 2 (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
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- 13 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 10 (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
- 3191 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 575 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- levofloxacin
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 Plasma Concentrations in Patients Receiving Renal Replacement Therapy NCT05373615 · started 2022 · scored riskier than 45% of active trials completed
- Levosimendan in Acute Kidney Injury Study NCT01720030 · started 2016 · scored riskier than 75% of active trials completed
- Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance NCT04147221 · started 2020 · scored riskier than 52% of active trials completed
- 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 NCT02142075 · started 2014 · scored riskier than 50% 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
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.