Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)
Model scores of the 29,894 trials active now.
Model score 13% 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 2015-05-31, after 2011-04-30 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 2015-05-31. 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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Collaborators: 13 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 8.9% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 16.0% (lowers risk) · Drug's FDA history
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Blinding: single (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectto screeningprior tomonths priorto determine
Phrases that lowered it: participantsrespiratorysolidallergicnasal -
Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 86 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 123 (lowers risk) · Sponsor's track record
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Maximum age: 45 (lowers risk) · Who can join
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 90.3% (raises risk) · Drug's FDA history
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Disease area, respiratory: Yes (raises risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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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
- 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
- principal investigator (typical: sponsor)
- Collaborators
- 13 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 4 (typical: 18)
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 123 (typical: 32)
- Sponsor's past termination rate
- 8.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 86 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 8 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 27828 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5531 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory, digestive
- Drugs matched to FDA substances
- bactroban, chlorhexidine, chlorhexidine gluconate, minocycline, mupirocin, rifampin, sulfamethoxazole, trimethoprim
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
- STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) NCT03489629 · started 2018 · scored riskier than 20% of active trials completed
- Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP) NCT01594827 · started 2012 · scored riskier than 21% of active trials completed
- Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients NCT01746095 · started 2013 · scored riskier than 35% of active trials completed
- AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis NCT03181932 · started 2017 · scored riskier than 20% of active trials completed
- Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients NCT04176328 · started 2019 · scored riskier than 12% 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.