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

• Status: Recruiting
• Conditions: Infection, Bloodstream
• Intervention / Treatment: Drug: antibiotic treatments

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: rita murri; Phone Number: 003930154945; Email: [email protected]

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Agostino Gemelli Irccs
    • Contact: RITA MURRI; Phone Number: 00390639154945; Email: [email protected]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

adult patients hospitalized at the Gemelli Polyclinic Foundation

Description

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

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

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: BACTERIUM-4407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No