Neonatal Vancomycin Trial
Model scores of the 29,894 trials active now.
Model score 13% 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 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 2020-04-01, after 2017-02-27 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 2020-04-01. 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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Collaborators: 12 (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: kgdialysishoursonsetand pharmacokinetics
Phrases that lowered it: countparticipantsparticipantthe efficacydl -
Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 24.0% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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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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Number of arms: 2 (raises risk) · Design
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Maximum age: 0.25 (raises risk) · Who can join
-
Drug's FAERS reports before start: 24618 (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
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 12 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 0.25 (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
- 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
- 24618 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3992 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- vancomycin
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
- Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis NCT01551394 · started 2012 · scored riskier than 56% of active trials completed
- Vancomycin Versus Daptomycin for the Treatment of Methicillin Resistant Staphylococcus Aureus (MRSA) Bacteremia NCT01975662 · started 2014 · scored riskier than 64% of active trials terminated
- 7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis NCT03280147 · started 2019 · scored riskier than 16% of active trials completed
- Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection NCT01191840 · started 2011 · scored riskier than 80% of active trials completed
- Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection NCT02365493 · started 2015 · scored riskier than 17% 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.