Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 7% 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 (876 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-11-30, after 2015-11-30 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 2016-11-30. 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) (raises risk) · Wording
Phrases that raised it: subjects withdiabetictreatment ofdiseaseinfections
Phrases that lowered it: evaluateand safetyefficacy andulnpatients -
Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
-
Minimum age: 12 (lowers risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports before start: 7682 (raises risk) · Drug's FDA history
-
Disease area, neurology: No (lowers risk) · Disease area
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
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 12 (typical: 18)
- Maximum age
- not given (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 50% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 7682 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 883 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, dermatology
- Drugs matched to FDA substances
- fusidate, fusidic acid, linezolid
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
- Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections NCT02569541 · started 2015 · scored riskier than 90% of active trials completed
- Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection NCT01252732 · started 2010 · scored riskier than 26% of active trials completed
- Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) NCT03405064 · started 2017 · scored riskier than 20% of active trials completed
- A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci NCT01519492 · started 2012 · scored riskier than 77% of active trials completed
- Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections NCT03137173 · started 2018 · scored riskier than 76% 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.