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Clinical Trials/NCT05985057
NCT05985057
Completed
Not Applicable

A Novel Approach to Antimicrobial Resistance: Machine Learning Predictions for Carbapenem-Resistant Klebsiella in ICUs

Kocaeli University1 site in 1 country289 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carbapenem Resistant Enterobacteriaceae Infection
Sponsor
Kocaeli University
Enrollment
289
Locations
1
Primary Endpoint
Risk of Carbapenem Resistant Klebsiella Infection
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study to predict carbapenem resistant Klebsiella spp. earlier in our patients monitored in our Intensive Care Unit in the future, using artificial intelligence.

Patients with bloodstream infection and pneumonia caused by Klebsiella spp. will be comparatively examined in two groups, as sensitive and resistant. Resistance will be attempted to be predicted with deep machine learning.

Detailed Description

Antimicrobial resistance is a globally increasing threat and has serious consequences on both public health and the economy. In an infection that may develop with a resistant microorganism, therapeutic options are limited, hence early and effective treatment that can be initiated by predicting resistance will make a difference in patient prognosis. Today, artificial intelligence and machine learning are changing our medical practice. When the literature is reviewed, there are studies suggesting that machine learning can predict antimicrobial resistance.Risk factors for carbapenem-resistant Klebsiella spp. have been previously identified. These previously identified risk factors will be evaluated retrospectively in our own patients and an algorithm related to the prediction of resistance will be developed with the help of machine learning. Our goal is to predict bacterial resistance earlier in our patients monitored in our Intensive Care Unit in the future, using artificial intelligence, and to facilitate our patients' access to early and effective treatment options. Secondarily, it is also aimed to provide economic benefits by preventing unnecessary antibiotic use. Access to patients' data will be obtained retrospectively through the hospital automation system. Publications in the literature will be examined, and the risk factors causing the development of infection with carbapenem-resistant Klebsiella spp. will be evaluated. Patients with carbapenem resistance and sensitivity will be compared in two separate subgroups. The obtained features will be classified using various decision trees and neural algorithms separately. The data obtained will be statistically compared in the distinction of resistance and sensitivity. Statistical evaluation was done with IBM SPSS 29.0 (IBM Corp., Armonk, NY, USA). Demographic data, descriptive statistics, Categorical variables will be expressed in terms of frequency (percentage). Categorical variables will be expressed with the chi-square test. The performance of Machine Learning algorithms will be evaluated by ROC analysis, AUC, classification accuracy, sensitivity, and specificity values will be calculated.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
June 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Volkan Alparslan

Medical Doctor

Kocaeli University

Eligibility Criteria

Inclusion Criteria

  • Patients monitored in our third-level intensive care unit between June 2017 and June 2023 will be evaluated retrospectively. Patients with pneumonia and bloodstream infection developed with Klebsiella spp. will be included in the study.

Exclusion Criteria

  • Patients under the age of 18 have not been included in the study.
  • Infections outside of the respiratory tract and bloodstream have not been included in the study.
  • Patients with respiratory tract colonization and without active inflammation have also not been included.

Outcomes

Primary Outcomes

Risk of Carbapenem Resistant Klebsiella Infection

Time Frame: 3 months

The sensitivity and specificity of a diagnostic method based on machine learning will be measured with the AUC-ROC curve (Area Under the Receiver Operating Characteristic curve)

Study Sites (1)

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