FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 15% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-01-31, after 2015-01-31 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 2020-01-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: donorreceivecontrolledto determineindex
Phrases that lowered it: patientscountefficacyneutrophilabsolute -
Sponsor's past termination rate: 23.1% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 60% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 40% (raises risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Blinding: none (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports before start: 5 (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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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
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (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
- 13 (typical: 32)
- Sponsor's past termination rate
- 23.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 5 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60% (typical: 85.6%)
- Drug's FAERS reports with a death
- 40% (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
- Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection NCT03353506 · started 2018 · scored riskier than 81% of active trials completed
- Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection NCT02743234 · started 2016 · scored riskier than 20% of active trials completed
- Fecal Transplantation for Primary Clostridium Difficile Infection NCT03796650 · started 2019 · scored riskier than 38% of active trials terminated
- Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection NCT03427229 · started 2016 · scored riskier than 25% of active trials completed
- Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH) NCT03005379 · started 2018 · scored riskier than 64% 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.