Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli

NCT02142751 on ClinicalTrials.gov Phase 3 Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (academic or other) Started 2014-07-31 Completed

Riskier than 78% of active trials

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (313 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2019-03-31, after 2014-07-31 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2019-03-31. 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: therapyhours24infectionheart
Phrases that lowered it: clinicalpharmacokineticstrialpositivepain
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 26.9% (raises risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Drug's FAERS reports marked serious: 96.9% (raises risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Keywords listed: 12 (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: academic or other (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Collaborators: 1 (raises risk) · Design
Blinding: none (raises risk) · Design
Disease area, infectious disease: Yes (lowers risk) · Disease area

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: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 12 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 4 (typical: 32)
Sponsor's past termination rate: 25% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 5 (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: 10427 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2099 (typical: 412.5)
Drug's FAERS reports marked serious: 96.9% (typical: 85.6%)
Drug's FAERS reports with a death: 26.9% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, urogenital
Drugs matched to FDA substances: ceftriaxone, fosfomycin, meropenem

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

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Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems NCT04876430 · started 2021 · scored riskier than 35% of active trials terminated
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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.