NCT07744321 Epidemiology and Overtime Genomic Evolution of Klebsiella Pneumoniae and Enterobacter Cloacae Complex (ECC) in Stools of ICU's Patients
| NCT ID | NCT07744321 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Caen |
| Condition | Longitudinal |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-01-20 |
| Primary Completion | 2027-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2023-01-20 with a primary completion date of 2027-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT07744321 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Longitudinal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07744321 currently recruiting?
Yes, NCT07744321 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Caen to inquire about joining.
Where is the NCT07744321 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT07744321 clinical trial?
NCT07744321 is sponsored by University Hospital, Caen. The trial plans to enroll 20 participants.