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

NCT05876598 | Recruiting

• 1 other identifier: BACTERIUM-4407
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Infection, Bloodstream

Outcome Measures

Primary Outcomes (2)

• 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"

  24 months

• Blood cultures

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

  24 months

Interventions

antibiotic treatments DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patients hospitalized at the Gemelli Polyclinic Foundation

You may qualify if:

• adult patients hospitalized at the Gemelli Polyclinic Foundation
• having at least one performed blood culture
• starting an antibiotic therapy

You may not qualify if:

• blood cultures with contaminants
• \<18 years old
• died after less than 48 hours from blood cultures positivity

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli Irccs

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rita Murri

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

rita murri

CONTACT

003930154945; rita.murri@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 25, 2023
• Study Start: November 3, 2021
• Primary Completion: June 15, 2025
• Study Completion: December 30, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)