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

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.

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Key information

Conditions

Longitudinal Bacterial Infections Bacterial Infections and Mycoses Enterobacter Cloacae Infection Enterobacteriaceae Infections Genomic Instability Genomic Stability Gram-Negative Bacterial Infections Infections Intensive Care Unit Klebsiella Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital

Caen, France

Location status: Recruiting

Location contact

LE HELLO

CONTACT

0231063106

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: NormandyKlebs

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2028
First posted: Aug 4, 2026
Registry last updated: Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed