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

Recruiting

• Conditions: Infection, Bloodstream

• Registration Number: NCT05876598
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-11-03
• Status Verified: 2023-03
• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-05-24
• Last Update Submitted: 2023-05-24
• Study First Posted: 2023-05-25
• Last Update Posted: 2023-05-25
• Primary Completion: 2025-06-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Policlinico Agostino Gemelli Irccs; 🇮🇹 Rome, Italy