Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
Model scores of the 29,894 trials active now.
Model score 18% 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
Completed on 2024-09-14, after 2020-04-17 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 2024-09-14. 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
-
Sponsor's past termination rate: 17.2% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: hoursdialysisfirst dosetolerability andand pharmacokinetics
Phrases that lowered it: participantsevaluate theparticipantto evaluateopen label -
Phase: 1 (lowers risk) · Design
-
Sponsor's past trials: 1280 (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 48.8% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 121 (lowers risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports marked serious: 95.1% (raises risk) · Drug's FDA history
-
Maximum age: 17 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 5 (lowers risk) · Design
-
Minimum age: 0.02 (lowers risk) · Who can join
-
Disease area, respiratory: Yes (raises risk) · Disease area
-
Drug's FAERS reports before start: 82 (lowers risk) · Drug's FDA history
-
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
- 5 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0.02 (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
- 1280 (typical: 32)
- Sponsor's past termination rate
- 17.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 121 (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
- 82 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 43 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 48.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- ceftolozane tazobactam
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
- Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010) NCT02266706 · started 2014 · scored riskier than 42% of active trials completed
- Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008) NCT02070757 · started 2014 · scored riskier than 45% of active trials completed
- 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
- A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia NCT01808092 · started 2013 · scored riskier than 98% of active trials completed
- Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia NCT03439124 · started 2017 · scored riskier than 67% 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.