Clinical trial Recruiting at 1 site Observational Ages 18 and up

Genomic changes of Klebsiella pneumoniae and Enterobacter cloacae in ICU patients over time

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

Run by University Hospital, Caen · NCT07744321 · Data updated 2026-11-12

This study tests how the gut bacteria Klebsiella pneumoniae and Enterobacter cloacae evolve over time in adults in ICUs.

More Intensive Care Unit trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorUniversity Hospital, Caen
Academic / other
Locations1 site (Caen)
StatusRecruiting
StartedJanuary 20, 2023
Main results expectedJanuary 20, 2027
Study endsJanuary 20, 2028
Registry record updatedAugust 4, 2026
Trial IDNCT07744321 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older admitted to medical or surgical ICUs with planned stay of 28 days or more and at least four rectal swabs, who speak French and are insured, without recent hospitalization.

Probably not a fit

Patients who do not meet the sampling requirements or who have an early discharge may not benefit from study findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults admitted to medical or surgical ICUs for at least 28 days, collecting rectal swabs to track the genomic changes of Klebsiella pneumoniae and Enterobacter cloacae over time. It aims to understand how these bacteria persist or evolve in the ICU environment and their potential links to infections. No interventions are given; the study analyzes samples to map longitudinal genomic stability and diversification. Eligible participants must be French-speaking adults with extended ICU stays and multiple swabs, with several inclusion and exclusion criteria to ensure reliable data. Results could inform infection control and future research on MDR organisms in critical care settings.

Why it matters

Potential benefit: If successful, findings could improve understanding of how these bacteria evolve in the ICU and inform strategies to prevent infections and transmission.

How similar studies have gone: Previous work has highlighted the importance of genomic characterization of Klebsiella and Enterobacter species in hospital settings, supporting the value of longitudinal genomic studies in ICUs.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Caen University Hospital
    Caen, France
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.