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

NCT07744321 | Recruiting

• 1 other identifier: 20-026
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Longitudinal; Klebsiella Infections; Intensive Care Unit; Genomic Stability; Enterobacter Cloacae Infection

Keywords

Klebsiella; Longitudinal genomic study; Enterobacter; ICU

Outcome Measures

Primary Outcomes (1)

• Diversity and evolution

  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 Outcomes (1)

• qPCR detection of Kpn

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Pregnant or lactating woman
• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stools Klebsiella pneumoniae isolates Enterobacter cloacae complex isolates

MeSH Terms

Conditions

Genomic Instability; Klebsiella Infections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: January 20, 2023
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)