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RecruitingNCT05876598BACTERIUMUpdated Mar 11, 2025

BACTERIUM: Study for a Machine-learning-based Model to Predict Bloodstream Infections

An observational study in Infection, Bloodstream, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study summary

An increase of healthcare-associated infections caused by multidrug- resistant organisms (MRDO) is currently observed. One of the main causes of the emergence of a MDRO infection is an overuse of antibiotics. Therefore, saving useless antibiotic treatment is currently a priority from a public health point of view. The evaluation of the risk of having a bloodstream infection will allow both activating faster treatment decisions (when the risk is significantly high) or to save useless resources in terms of diagnostic tests and treatments, also limiting the potential for side effects (when the risk is significantly low).

02

Conditions studied

  • Infection, Bloodstream
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adult patients hospitalized at the Gemelli Polyclinic Foundation

Inclusion criteria

  1. adult patients hospitalized at the Gemelli Polyclinic Foundation
  2. having at least one performed blood culture
  3. starting an antibiotic therapy

Exclusion criteria

Exclusion Criteria:

  1. blood cultures with contaminants
  2. \<18 years old
  3. died after less than 48 hours from blood cultures positivity
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No

Interventions

  • Drugantibiotic treatments

    The outcome of the study will be to implement Prediction Models to support clinicians for the assessment of risk of having a bloodstream infection.

06

What researchers measure

Primary outcomes

  1. Rate of appropriate antibiotic therapy in patients with bloodstream infections

    1) number of patients with bloodstream infections with appropriate antibiotic therapy before and after the application of the predictive model "Bacterium"

    Time frame: 24 months

  2. Blood cultures

    number of blood cultures done before and after the application of the predictive model "Bacterium"

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05876598
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
May 25, 2023
Start date
Nov 3, 2021
Primary completion
Jun 15, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Mar 11, 2025

Study contacts

rita murri
Contact
rita.murri@policlinicogemelli.it
003930154945
Rita Murri
principal investigator · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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