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

Sponsor
Kocaeli University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05985057
Collaborator
(none)
300
1
4.9
60.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Artificial intelligence

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Novel Approach to Antimicrobial Resistance: Machine Learning Predictions for Carbapenem-Resistant Klebsiella in ICUs
Anticipated Study Start Date :
Aug 2, 2023
Anticipated Primary Completion Date :
Nov 2, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients with carbapenem resistant Klebsiella spp. infection

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

Patients with carbapenem sensitive Klebsiella spp. infection

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

Outcome Measures

Primary Outcome Measures

  1. To predict bacterial resistance via artifical intelligence [3 months]

    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.

Secondary Outcome Measures

  1. To provide economic benefit [3 months]

    Secondarily, it is also aimed to provide economic benefits by preventing unnecessary antibiotic use.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kocaeli University Kocaeli Turkey

Sponsors and Collaborators

  • Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Volkan Alparslan, Medical Doctor, Kocaeli University
ClinicalTrials.gov Identifier:
NCT05985057
Other Study ID Numbers:
  • GOKAEK-2023/12.32
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023