Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection
Model scores of the 29,894 trials active now.
Model score 15% 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 6% of the time (776 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-04-03, after 2016-04-01 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 2019-04-03. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientintravenousacuteinfusionhours
Phrases that lowered it: patients whoto evaluateevaluate thedayaged -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports marked serious: 65.2% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 101 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 2.2% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Maximum age: 0.08 (raises risk) · Who can join
-
Number of arms: 3 (lowers risk) · Design
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Minimum age: not given (raises risk) · Who can join
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Sponsor's past termination rate: 7.5% (raises risk) · Sponsor's track record
-
Disease area, neurology: No (lowers risk) · Disease area
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Responsible party: sponsor (lowers 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
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 0.08 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 53 (typical: 32)
- Sponsor's past termination rate
- 7.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 101 (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
- 46 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17 (typical: 412.5)
- Drug's FAERS reports marked serious
- 65.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- dalbavancin
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
- A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years. NCT01946568 · started 2013 · scored riskier than 23% of active trials completed
- Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections NCT00678106 · started 2008 · scored riskier than 9% of active trials completed
- An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants NCT00942149 · started 2010 · scored riskier than 31% of active trials completed
- Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections NCT01431339 · started 2011 · scored riskier than 41% of active trials completed
- Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections NCT01339091 · started 2011 · scored riskier than 42% 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.