Epidemiology and Overtime Genomic Evolution of Klebsiella Pneumoniae and Enterobacter Cloacae Complex (ECC) in Stools of ICU's Patients | NCT07744321

NCT07744321

Overview

NCT ID: NCT07744321
Lead Sponsor: University Hospital, CaenOTHER
Official Title: Epidemiology and Overtime Genomic Evolution of Klebsiella Pneumoniae and Enterobacter Cloacae Complex (ECC) in Stools of ICU's Patients
Brief Summary: 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Jan 20, 2023Actual
Primary Completion Date: Jan 20, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Type: Observational
Phase: No data available
Enrollment: 20Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: No data available
Locations: Caen University Hospital

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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.

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