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

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).

Study Overview



Intervention / Treatment

Study Type


Enrollment (Estimated)


Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers


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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of appropriate antibiotic therapy in patients with bloodstream infections
Time Frame: 24 months
1) number of patients with bloodstream infections with appropriate antibiotic therapy before and after the application of the predictive model "Bacterium"
24 months
Blood cultures
Time Frame: 24 months
number of blood cultures done before and after the application of the predictive model "Bacterium"
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2021

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?


Drug and device information, study documents

Studies a U.S. FDA-regulated drug product


Studies a U.S. FDA-regulated device product


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