Effect of Ceftobiprole on Human Intestinal Microflora
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 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 2009-06-30, after 2009-04-30 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 2009-06-30. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: the trialof studypurpose ofadministrationthe purpose
Phrases that lowered it: healthyvolunteersintestinaleffect ofunit -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Blinding: none (lowers risk) · Design
-
Sponsor's past termination rate: 7.7% (raises risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Maximum age: 40 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 8 (raises risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Primary purpose: basic science (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
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 40 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 13 (typical: 32)
- Sponsor's past termination rate
- 7.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ceftobiprole
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 Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers NCT01789528 · started 2013 · scored riskier than 6% of active trials completed
- Pharmacokinetics of Ceftaroline in Normal and Obese Subjects NCT01648127 · started 2012 · scored riskier than 2% of active trials completed
- A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately NCT01534247 · started 2012 · scored riskier than 8% of active trials completed
- Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU NCT00770978 · started 2008 · scored riskier than 15% of active trials completed
- Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics NCT02527681 · started 2016 · scored riskier than 21% 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.