A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
Model scores of the 29,894 trials active now.
Model score 16% 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 8% of the time (780 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-09-17, after 2020-02-19 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 2024-09-17. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports with a death: 75% (raises risk) · Drug's FDA history
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Number of arms: 3 (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: 17 (raises risk) · Who can join
-
Minimum age: 0.25 (lowers risk) · Who can join
-
Sponsor's past trials: 53 (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
-
Drug's FAERS reports before start: 4 (lowers risk) · Drug's FDA history
-
Disease area, neurology: No (lowers risk) · Disease area
-
Collaborators: 0 (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
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0.25 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 53 (typical: 32)
- Sponsor's past termination rate
- 7.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 13 (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
- 4 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 75% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- cefiderocol
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
- A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants NCT04335539 · started 2020 · scored riskier than 29% of active trials completed
- A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants NCT06086626 · started 2024 · scored riskier than 67% of active trials completed
- Cefazolin PK Study 3g vs 2g NCT05309304 · started 2022 · scored riskier than 4% of active trials completed
- Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults NCT05205486 · started 2022 · scored riskier than 5% of active trials completed
- Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia NCT03862040 · started 2019 · scored riskier than 54% of active trials terminated
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.