Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 10% 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 2021-09-19, after 2020-02-10 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 2021-09-19. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientspatientlimitdlenrollment
Phrases that lowered it: pharmacokineticsoraldrugdosingmoderate -
Primary purpose: other (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports with a death: 29.5% (raises risk) · Drug's FDA history
-
Design: single group (raises risk) · Design
-
Sponsor's past termination rate: 7.5% (lowers risk) · Sponsor's track record
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 94.6% (raises risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Has a data monitoring committee: No (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 9 (raises risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Maximum age: 54 (lowers risk) · Who can join
-
Drug's FAERS reports before start: 7940 (raises risk) · Drug's FDA history
-
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
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 54 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 40 (typical: 32)
- Sponsor's past termination rate
- 7.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 7940 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1058 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.5% (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
- PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN NCT04983901 · started 2021 · scored riskier than 89% of active trials completed
- Imipenem/Cilastatin/Relebactam PK in ECMO NCT04493151 · started 2021 · scored riskier than 54% 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
- Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury NCT03403751 · started 2018 · scored riskier than 76% of active trials terminated
- Study of the Safety, Tolerability, and Efficacy of Relebactam (MK-7655) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone to Treat Complicated Intra-Abdominal Infection [cIAI] (MK-7655-004) NCT01506271 · started 2012 · scored riskier than 72% 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.