Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 0% of the time (33 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-01-13, after 2019-01-11 start.
Reason given by the sponsor: “enrollment”
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 2021-01-13. 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: subjectplacebokidneykgsubjects
Phrases that lowered it: efficacyevaluate theto evaluatepatientssafety -
Accepts healthy volunteers: No (raises risk) · Who can join
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Maximum age: 99 (lowers risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: 35.7% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 111 (lowers risk) · Sponsor's track record
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Sponsor's past termination rate: 6.9% (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 1214 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Blinding: double (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports before start: 28 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 78.6% (lowers risk) · Drug's FDA history
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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 99 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 1214 (typical: 32)
- Sponsor's past termination rate
- 6.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 111 (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
- 28 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4 (typical: 412.5)
- Drug's FAERS reports marked serious
- 78.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 35.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- 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
- Treatment of Recurrent Clostridium Difficile Infection With RBX7455 NCT02981316 · started 2016 · scored riskier than 70% of active trials completed
- Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea NCT01925417 · started 2013 · scored riskier than 90% of active trials completed
- A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI) NCT04891965 · started 2020 · scored riskier than 54% of active trials completed
- Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis NCT03006809 · started 2017 · scored riskier than 35% of active trials completed
- Placebo Controlled Study of Fecal Microbiota Transplant (FMT) for a First or Second Episode of C. Difficile Infection in Adults Using a Frozen Encapsulated Inoculum NCT02343328 · started 2015 · scored riskier than 51% of active trials terminated
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.