Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
Model scores of the 29,894 trials active now.
Model score 26% for any early termination, 19% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-11-24, after 2021-10-04 start.
Reason given by the sponsor: “other”
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 2023-11-24. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientschemotherapytransplantationpriorcell
Phrases that lowered it: evaluatehistoryinvestigatefoodintestinal -
Sponsor's past termination rate: 17.6% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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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: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 25% (raises risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 48 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 75% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 15 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (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
- 17 (typical: 32)
- Sponsor's past termination rate
- 17.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 48 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- fecal microbiota
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
- Fecal Microbiota Transplantation for Carbapenem-resistant Enterobacteriaceae NCT04146337 · started 2020 · scored riskier than 28% of active trials completed
- Fecal Microbiota Transplantation for CRE/VRE NCT03479710 · started 2018 · scored riskier than 41% of active trials completed
- Fecal Microbiota Transplantation for Eradication of CRE NCT03167398 · started 2018 · scored riskier than 44% of active trials completed
- Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis NCT03998488 · started 2020 · scored riskier than 36% of active trials completed
- Fecal Microbiota Transplantation for Carbapenem Resistant Enterobacteriaceae NCT04790565 · started 2021 · scored riskier than 30% 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.