Clinical trial NCT05985057: A Novel Approach to Antimicrobial Resistance: Machine Learning Predictions for Carbapenem-Resistant Klebsiella in ICUs
Official title: A Novel Approach to Antimicrobial Resistance: Machine Learning Predictions for Carbapenem-Resistant Klebsiella in ICUs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbapenem Resistant Enterobacteriaceae Infection
Artificial Intelligence
Intensive Care Unit
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Risk of Carbapenem Resistant Klebsiella Infection
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
References: