Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)
Model scores of the 29,894 trials active now.
Model score 15% 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 (876 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-09-17, after 2015-03-25 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 2018-09-17. 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
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Sponsor's past termination rate: 32.1% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Blinding: single (lowers risk) · Design
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Drug's FAERS reports with a death: 17.4% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 17 (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: therapyreceptor18 yearsin subjectsto study
Phrases that lowered it: dayparticipantssafety offormulationhypersensitivity -
Sponsor's past trials: 53 (lowers risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 11 (lowers 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: 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
- 12 (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
- 32.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 9 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 61249 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 10340 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, dermatology
- Drugs matched to FDA substances
- aztreonam, cefazolin, cephalexin, clindamycin, flucloxacillin, linezolid, metronidazole, tedizolid
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 of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013) NCT02750761 · started 2016 · scored riskier than 12% of active trials completed
- A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014) NCT03217565 · started 2019 · scored riskier than 28% of active trials completed
- A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018) NCT03176134 · started 2019 · scored riskier than 27% of active trials completed
- Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI) NCT02066402 · started 2014 · scored riskier than 22% of active trials completed
- A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044) NCT06609161 · started 2024 · scored riskier than 3% 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.