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

Artificial Intelligence Clinical Trial

— ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985057
• Other study ID #: GOKAEK-2023/12.32
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Kocaeli University
• Contact: volkan Alparslan
• Phone: 905059374578
• Email: volknn[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: June 22, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Enterobacteriaceae Infections
• Intensive Care Unit

Intervention

Other:
• Artificial intelligence
Prediction of carbapenem resistance via deep machine learning model

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of Carbapenem Resistant Klebsiella Infection	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)	3 months

External Links

•   Using Machine Learning to Predict Antimicrobial Resistance of Acinetobacter Baumannii, Klebsiella Pneumoniae and Pseudomonas Aeruginosa Strains