Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (453 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
Completed on 2012-06-30, after 2010-10-31 start.
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 2012-06-30. 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: 0% (lowers risk) · Sponsor's track record
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Design: factorial (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: to determinetolerabilityregimenpregnancycompared
Phrases that lowered it: to evaluatetrialsnormaltuberculosistb -
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 13.7% (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 2 (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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Collaborators: 1 (raises risk) · Design
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Disease area, infectious disease: Yes (lowers risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 250 (raises risk) · Drug's FDA history
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Drug's FAERS reports before start: 1295 (raises 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 15 (typical: 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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 1295 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 250 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, infectious disease
- Drugs matched to FDA substances
- moxifloxacin
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
- Rifampicin Explorative PK Study for Tuberculous Meningitis Comparing Oral and Intravenous Preparation NCT01802502 · started 2013 · scored riskier than 23% of active trials completed
- High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study NCT02169882 · started 2014 · scored riskier than 47% of active trials completed
- Pharmacokinetic Study of Linezolid for TB Meningitis NCT03537495 · started 2021 · scored riskier than 19% of active trials completed
- Optimizing Treatment to Improve TBM Outcomes in Children NCT02958709 · started 2017 · scored riskier than 38% of active trials completed
- Adjunctive Linezolid for the Treatment of Tuberculous Meningitis NCT04021121 · started 2021 · scored riskier than 37% 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.