Carbapenemase-Producing EnterobacteriaceaeCADECONCT06839911
Prevention of Carbapenemase-producing Enterobacteriaceae Epidemics: Evaluation of a Simplified Contact Screening Policy (CADECO)
An observational study of Carbapenemase-Producing Enterobacteriaceae, run by University Hospital, Brest at 1 site in France.
Trial summary
In France, carbapenemase-producing Enterobacteriaceae (CPE) are a significant concern due to their emergence. Efforts to limit their spread focus on reducing antibiotic selection pressure and preventing patient-to-patient transmission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbapenemase-Producing Enterobacteriaceae
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2025to 30 Apr 2025
- 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: Patient carrying CPE according to HCSP definitions (2010), hospitalized for more than 24 hours at Brest University Hospital in a medicine, surgery, or obstetrics department between 2012 and 2023
Who may be able to join
- Adult patient
- Patient carrying CPE according to HCSP definitions (2010)
- Hospitalized for more than 24 hours at Brest University Hospital in a medicine, surgery, or obstetrics department between 2012 and 2023
- Patient affiliated with a social security system
Who cannot join
- Patients under legal protection (guardianship, curatorship)
- Deceased patients
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Carbapenemase-producing Enterobacteriaceae Epidemics: Evaluation of a Simplified Contact Screening Policy
In France, carbapenemase-producing Enterobacteriaceae (CPE) are a significant concern due to their emergence. Efforts to limit their spread focus on reducing antibiotic selection pressure and preventing patient-to-patient transmission. The recommendations issued by the High Council for Public Health in 2010, updated in 2013 and 2019, emphasize the importance of identifying high-risk patients (those who have been hospitalized abroad in the past year) and implementing contact precautions, including single-room isolation and the use of protective clothing. Additional measures include assigning dedicated staff to CPE carriers when possible and conducting systematic weekly screening of all individuals exposed to the same medical or paramedical team, known as contact patient monitoring.
Despite their importance, these recommendations are challenging to implement. Firstly, they require significant resources due to the human and material constraints faced by healthcare systems. Secondly, a large number of contact patients are lost to follow-up and are not screened. The increasing prevalence of CPE carriers has further exacerbated these difficulties.
Read more
Epidemic outbreaks, defined by at least one secondary case of CPE carriage among contact patients, require additional control measures. French recommendations for managing an epidemic situation include halting patient transfers between departments, stopping new admissions, and organizing different sectors (CPE carriers, contact patients, and new patients) with dedicated staff for each sector until the outbreak is controlled (with three weeks without a new positive test among contact patients). These measures are even more costly and require time for discussions with hospital management, service reorganization, and hiring additional staff. The difficulties in implementing these measures can have negative effects, such as reduced quality of care and increased staff fatigue.
To address these challenges, some hospitals have adapted their strategies by replacing dedicated teams with a "forward movement" approach and conducting selective screening for only a subset of patients exposed to carriers, based on assessments by infection prevention and control (IPC) specialists. The simplified CPE management protocol was developed in late 2017 at our center. Before that date, French national recommendations for managing carriers and identifying outbreaks were followed. All contacts of a CPE carrier were screened weekly. In 2017, a CPE cohorting unit was implemented at the hospital level for a short period of approximately six months before being discontinued due to difficulties in maintaining continuity of care. In 2018, the selection of a subset of contact patients for screening during each CPE carrier's stay was gradually introduced, without a corresponding change in the definition of an epidemic.
The screening sample is determined by the IPC team based on the duration of contact with the CPE carrier, risk assessment, and geographical proximity. In case of an outbreak, screening is then expanded, and additional measures are implemented as previously described.
This is a retrospective cohort study including adult patients carrying carbapenemase-producing Enterobacteriaceae and comparing stays that resulted in outbreaks to those without outbreaks at Brest University Hospital in the medicine, surgery, or obstetrics departments.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of a CPE outbreak
is defined as the identification of CPE with the same resistance enzyme in at least one contact patient of a known carrier.
Measured: untill 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Feb 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenemase-Producing EnterobacteriaceaeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839911
- Sponsor's protocol ID
- 29BRC25.0003 - CADECO
- Acronym
- CADECO
- Status last verified
- Jan 2025
- First submitted
- 11 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Carbapenemase-producing Enterobacteriaceae Epidemics: Evaluation of a Simplified Contact Screening Policy
- ClinicalTrials.gov ID
- NCT06839911
- Acronym / sponsor ID
- CADECO / 29BRC25.0003 - CADECO
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
In France, carbapenemase-producing Enterobacteriaceae (CPE) are a significant concern due to their emergence. Efforts to limit their spread focus on reducing antibiotic selection pressure and preventing patient-to-patient transmission. The recommendations issued by the High Council for Public Health in 2010, updated in 2013 and 2019, emphasize the importance of identifying high-risk patients (those who have been hospitalized abroad in the past year) and implementing contact precautions, including single-room isolation and the use of protective clothing. Additional measures include assigning dedicated staff to CPE carriers when possible and conducting systematic weekly screening of all individuals exposed to the same medical or paramedical team, known as contact patient monitoring.
Despite their importance, these recommendations are challenging to implement. Firstly, they require significant resources due to the human and material constraints faced by healthcare systems. Secondly, a large number of contact patients are lost to follow-up and are not screened. The increasing prevalence of CPE carriers has further exacerbated these difficulties.
Epidemic outbreaks, defined by at least one secondary case of CPE carriage among contact patients, require additional control measures. French recommendations for managing an epidemic situation include halting patient transfers between departments, stopping new admissions, and organizing different sectors (CPE carriers, contact patients, and new patients) with dedicated staff for each sector until the outbreak is controlled (with three weeks without a new positive test among contact patients). These measures are even more costly and require time for discussions with hospital management, service reorganization, and hiring additional staff. The difficulties in implementing these measures can have negative effects, such as reduced quality of care and increased staff fatigue.
To address these challenges, some hospitals have adapted their strategies by replacing dedicated teams with a "forward movement" approach and conducting selective screening for only a subset of patients exposed to carriers, based on assessments by infection prevention and control (IPC) specialists. The simplified CPE management protocol was developed in late 2017 at our center. Before that date, French national recommendations for managing carriers and identifying outbreaks were followed. All contacts of a CPE carrier were screened weekly. In 2017, a CPE cohorting unit was implemented at the hospital level for a short period of approximately six months before being discontinued due to difficulties in maintaining continuity of care. In 2018, the selection of a subset of contact patients for screening during each CPE carrier's stay was gradually introduced, without a corresponding change in the definition of an epidemic.
The screening sample is determined by the IPC team based on the duration of contact with the CPE carrier, risk assessment, and geographical proximity. In case of an outbreak, screening is then expanded, and additional measures are implemented as previously described.
This is a retrospective cohort study including adult patients carrying carbapenemase-producing Enterobacteriaceae and comparing stays that resulted in outbreaks to those without outbreaks at Brest University Hospital in the medicine, surgery, or obstetrics departments.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient carrying CPE according to HCSP definitions (2010), hospitalized for more than 24 hours at Brest University Hospital in a medicine, surgery, or obstetrics department between 2012 and 2023
Key inclusion criteria (4 listed)
- Adult patient
- Patient carrying CPE according to HCSP definitions (2010)
- Hospitalized for more than 24 hours at Brest University Hospital in a medicine, surgery, or obstetrics department between 2012 and 2023
- Patient affiliated with a social security system
Key exclusion criteria (3 listed)
- Patients under legal protection (guardianship, curatorship)
- Deceased patients
- Refusal to participate
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
Detection of a CPE outbreak
Time frame: untill 2022
is defined as the identification of CPE with the same resistance enzyme in at least one contact patient of a known carrier.
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 21 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Carbapenemase-Producing Enterobacteriaceae, run by University Hospital, Brest 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of a CPE outbreak (time frame: untill 2022). 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 21 Feb 2025.