New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 2% 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 (59 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-06-05, after 2017-09-18 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 2020-06-05. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 100% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: enrollmentpriorinfectionplacebocirrhosis
Phrases that lowered it: visitparticipantparticipantshavingand safety -
Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 17.9% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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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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Number of arms: 4 (lowers risk) · Design
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Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports marked serious: 92.2% (raises risk) · Drug's FDA history
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Drug's FAERS reports before start: 23961 (raises risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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
- 3 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 100% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 23961 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4216 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, urogenital
- Drugs matched to FDA substances
- ceftriaxone, ertapenem, fosfomycin, gentamicin
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
- Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea NCT02257918 · started 2014 · scored riskier than 9% of active trials completed
- Experimental Human Infection With Neisseria Gonorrhoeae NCT03840811 · started 2017 · scored riskier than 7% of active trials completed
- Zoliflodacin in Uncomplicated Gonorrhoea NCT03959527 · started 2019 · scored riskier than 8% of active trials completed
- A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea NCT04010539 · started 2019 · scored riskier than 12% of active trials completed
- Trial to Assess the Efficacy of F598 in Preventing an Experimental Urethral Infection With N. Gonorrhoeae in Healthy Males NCT03222401 · started 2017 · scored riskier than 3% 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.