Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis
Model scores of the 29,894 trials active now.
Model score 22% 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 13% of the time (331 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
Terminated on 2017-02-02, after 2014-03-19 start.
Reason given by the sponsor: “enrollment”
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 2017-02-02. 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: boneivtherapypatientintravenous
Phrases that lowered it: oraldiabeticclinicaldiabeteslong -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 10% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 18.7% (lowers risk) · Drug's FDA history
-
Responsible party: principal investigator (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 3 (lowers risk) · Design
-
Blinding: none (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, infectious disease: Yes (lowers risk) · Disease area
-
Disease area, musculoskeletal: Yes (raises risk) · Disease area
-
Drugs with FDA adverse-event history: 16 (lowers risk) · Drug's FDA history
-
Sponsor's past trials: 20 (raises risk) · Sponsor's track record
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
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (typical: 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
- 20 (typical: 32)
- Sponsor's past termination rate
- 10% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 16 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 128270 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18438 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, metabolic, musculoskeletal, endocrine
- Drugs matched to FDA substances
- aztreonam, cefepime, ciprofloxacin, clindamycin, daptomycin, linezolid, meropenem, metronidazole
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
- Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis NCT05177107 · started 2021 · scored riskier than 35% of active trials terminated
- Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment NCT01199783 · started 2011 · scored riskier than 16% of active trials terminated
- Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis NCT02685033 · started 2016 · scored riskier than 69% of active trials completed
- Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis NCT03091439 · started 2017 · scored riskier than 70% of active trials terminated
- Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers NCT02447172 · started 2015 · 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.