Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 3% 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 (81 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-08-05, after 2017-01-31 start.
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 2022-08-05. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientseligiblebreastiibrain
Phrases that lowered it: tbcontainingto evaluatearthritisevaluate the -
Collaborators: 14 (lowers risk) · Design
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Number of arms: 4 (lowers 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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Drug's FAERS reports with a death: 16.9% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Phase: 2/3 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises 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
- 2/3 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 14 (typical: 0)
- Keywords listed
- 7 (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
- 5 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 15923 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3819 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- bedaquiline, clofazimine, linezolid, moxifloxacin, pretomanid
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
- Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients NCT03338621 · started 2018 · scored riskier than 32% of active trials completed
- Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB NCT04629378 · started 2020 · scored riskier than 11% of active trials completed
- An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis NCT02454205 · started 2015 · scored riskier than 11% of active trials completed
- Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care NCT04062201 · started 2019 · scored riskier than 16% of active trials completed
- Evaluating Newly Approved Drugs for Multidrug-resistant TB NCT02754765 · started 2016 · scored riskier than 38% 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.