NCT05985057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

August 2, 2023

Last Update Submit

April 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients with carbapenem resistant Klebsiella spp. infection

Other: Artificial intelligence

Patients with carbapenem sensitive Klebsiella spp. infection

Other: Artificial intelligence

Interventions

Prediction of carbapenem resistance via deep machine learning model

Patients with carbapenem resistant Klebsiella spp. infectionPatients with carbapenem sensitive Klebsiella spp. infection

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (1)

  • Alparslan V, Guler O, Inner B, Duzgun A, Baykara N, Kus A. A novel approach to antimicrobial resistance: Machine learning predictions for carbapenem-resistant Klebsiella in intensive care units. Int J Med Inform. 2025 Mar;195:105751. doi: 10.1016/j.ijmedinf.2024.105751. Epub 2024 Dec 7.

Related Links

MeSH Terms

Interventions

Artificial Intelligence

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

December 1, 2023

Primary Completion

June 22, 2024

Study Completion

June 30, 2024

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations