LongitudinalNormandyKlebsNCT07744321
Epidemiology and Overtime Genomic Evolution of Klebsiella Pneumoniae and Enterobacter Cloacae Complex (ECC) in Stools of ICU's Patients
An observational study of Longitudinal and Genomic Stability, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Longitudinal, Genomic Stability, Klebsiella Infections
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2023to 20 Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen
LE HELLO, 0231063106
About this study
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, Genomic Stability, Klebsiella Infections, Enterobacter Cloacae Infection, Intensive Care Unit
- Keywords
- Klebsiella, Longitudinal genomic study, Enterobacter, ICU
- Medical subject headings
- Genomic Instability, Klebsiella Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
qPCR detection of Kpn
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start20 Jan 2023
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LongitudinalStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744321
- Sponsor's protocol ID
- 20-026
- Acronym
- NormandyKlebs
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Overtime Genomic Evolution of Klebsiella Pneumoniae and Enterobacter Cloacae Complex (ECC) in Stools of ICU's Patients
- ClinicalTrials.gov ID
- NCT07744321
- Acronym / sponsor ID
- NormandyKlebs / 20-026
- Conditions
- Longitudinal, Genomic Stability, Klebsiella Infections, Enterobacter Cloacae Infection, Intensive Care Unit
- Keywords
- Klebsiella, Longitudinal genomic study, Enterobacter, ICU
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
qPCR detection of Kpn
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for Longitudinal
Not yet recruitingObservational study
Longitudinal Natural History Protocol for PRKN- and PINK1-Linked PD
PARKINSON DIS
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Longitudinal and Genomic Stability, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diversity and evolution (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.