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

Обзор

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.

Первичные конечные точки

• Diversity and evolution [Срок оценки: 1 year]

Вторичные конечные точки (1)

• qPCR detection of Kpn [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Caen University Hospital — Caen

Идентификаторы

NCT: NCT07744321 · 20-026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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