Epidemiology and Overtime Genomic Evolution of Klebsiella Pneumoniae and Enterobacter Cloacae Complex (ECC) in Stools of ICU's Patients (NormandyKlebs)

July 30, 2026 updated by: University Hospital, Caen

Infections are one of the major threats for inpatients, even more for patients hospitalized in intensive care units (ICUs). They are responsible for an important increase of morbidity and mortality rates as well as a burst of medical costs since approximatively 50% of ICU patients acquire an infection during their hospitalization and 60% of attributable deaths (Vincent et al. 2009). In ICUs, patients are commonly colonized or infected by a small contingent of multidrug-resistant (MDR) isolates gathered under the acronym "ESKAPE bugs" for Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter spp. (Pendleton et al. 2013; Rice 2010; Reardon 2014). Moreover, it is clearly established now, that epidemiological characterization in K. pneumoniae and E. cloacae isolates seemed to be an major step due to the existence of potential hyper-virulent and/or multidrug resistant strains (Lam et al. 2018; Moradigaravand et al. 2016).

The aim of this study is the investigation of the overtime clonal diversity evolution of Klebsiella pneumoniae (Kpn) and Enterobacter cloacae complex (ECC) strains in long-term hospitalized patients (more than 28 days of hospitalization). To assess that objective, we will undertake a longitudinal monocentric, prospective study, based on weekly stool's samples done in ICUs patients and sent to our laboratory for MDR bacteria screening during their stay in reanimation wards and also, if possible, in their downstream wards especially in neurosurgery.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Recruiting
        • Caen University hospital
        • Contact:
          • LE HELLO
          • Phone Number: 0231063106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Long-term hospitalized patients (≥ 28 days and 4 swabs) in the surgical and medical ICU departments of the CHU de CAEN and potentially, depending on the course of care, in the neurosurgery department of the CHU de CAEN.

Description

Inclusion Criteria:

  • Patient ≥18 years old.
  • Hospitalization in medical and / or surgical ICU of a duration greater than or equal to 28 days and the production of 4 rectal swabs.
  • Absence of hospitalization in the last 4 months before inclusion
  • French speaking patient
  • Patient affiliated to the social security system
  • Patient having received an informed opinion on the study and collection of the non-opposition to the latter
  • Person of trust or family member who has received an informed opinion on the study and the collection of non-opposition to the latter when the patient is judged as incapable of expressing his non-opposition.

Exclusion Criteria:

  • Pregnant or lactating woman
  • Hospitalization within 4 months before inclusion
  • Patient whose hospital stay is <28 days or rectal swabs less than 4
  • Absence of Kpn or ECC in the first rectal sample taken
  • Patient under guardianship / curatorship
  • Patient deprived of liberty
  • Patient under judicial protection
  • Patient not affiliated to the social security system
  • Refusal to participate in the study requested by the patient or the designated confidential counselor or a designated family member.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Enrolling patients
This study will be carried out in patients hospitalized in ICUs of University Hospital of Caen and when possible with a minimum of associated comorbidities. The "ideal" eligible patient should be people hospitalized for physical injuries after a road traffic accident, spinal or neuro-brain injuries or also, massive cerebrovascular accident, in young patients. The minimal delay for the enrollment of patients is 4 consecutive weeks of stay in ICUs. A rectal swab will be performed at the day of entrance in ICU and will be reiterate each week until the ICUs discharge or if it is possible until the end of hospitalization. Moreover, if any patient develops a deep infection with a Kp or ECC isolated from the clinical sample. Strains obtained from those cases will be enrolled too.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diversity and evolution
Time Frame: 1 year
The objective is to study the diversity and the evolutionary dynamics of Kpn and / or ECC populations in the same individual hospitalized over a long period (≥ 28 days and 4 swabs) in the intensive care unit and if possible in follow-up care. First, by analysis of the genomic sequences obtained for each isolated bacterial strain, a determination of the diversity of Kpn and / or ECC strains within the digestive microbiota of patients hospitalized for the long term will be conducted by analysis of the MLST obtained during the study period.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qPCR detection of Kpn
Time Frame: 1 year
A more technical and timely analysis will be undertaken to determine the correspondence between real-time PCR and bacterial culture on enriched agar in order to allow the implementation of a simple, efficient diagnostic tool allowing for important information rendering in the patient management.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

January 20, 2028

Study Registration Dates

First Submitted

July 30, 2026

First Submitted That Met QC Criteria

July 30, 2026

First Posted (Actual)

August 4, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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