Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia
Model scores of the 29,894 trials active now.
Model score 24% 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 2021-05-07, after 2020-06-15 start.
Reason given by the sponsor: “business”
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 2021-05-07. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectsacutesubjectfailureage
Phrases that lowered it: open labelbloodlabel singlepharmacokinetic28 -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 15.5% (raises risk) · Sponsor's track record
-
Sponsor's past trials: 1900 (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 27.7% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 145 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports marked serious: 94.2% (raises risk) · Drug's FDA history
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Minimum age: 0.25 (lowers risk) · Who can join
-
Maximum age: 17 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
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Disease area, respiratory: Yes (raises risk) · Disease area
-
Collaborators: 1 (raises risk) · Design
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Blinding: none (lowers risk) · Design
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Drugs with FDA adverse-event history: 3 (lowers 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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 0.25 (typical: 18)
- Maximum age
- 17 (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
- 1900 (typical: 32)
- Sponsor's past termination rate
- 15.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 145 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 5653 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 901 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- avibactam, avibactam ceftazidime, ceftazidime
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
- Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants. NCT04126031 · started 2020 · scored riskier than 90% of active trials terminated
- Plasma Pharmacokinetics (PK) & Lung Penetration of Ceftolozane/Tazobactam in Participants With Pneumonia (MK-7625A-007) NCT02387372 · started 2015 · scored riskier than 43% of active trials completed
- Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections NCT01893346 · started 2013 · scored riskier than 36% of active trials completed
- Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia NCT01081964 · started 2010 · scored riskier than 86% of active trials terminated
- A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101 NCT05629741 · started 2022 · scored riskier than 7% 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.