Enterobacteriaceae InfectionsCARBEHPADNCT03401242
Prevalence of ESBL and CPE in French Nursing Homes
An observational study of Enterobacteriaceae Infections, run by Nantes University Hospital at 1 site in France.
Trial summary
CARBEHPAD is a multicentric randomized prevalence study aiming to assess the frequency of Enterobacteriaceae (ESLB) and carbapenemase producing Enterobacteriaceae (CPE) carriage in Pays de la Loire nursing homes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enterobacteriaceae Infections
- How many people
- 734 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2018to 14 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1000 residents of the nursing homes of the 5 departments of Pays de la Loire will be included in this study protocol. Participants in the study will be randomly sampled according to a two-stage sampling design.
Who may be able to join
- Resident present in the nursing home on the day of the survey.
- Resident having agreed to be included in the study.
- Resident with a social security number.
Who cannot join
- Resident non-compliant with sampling protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Prevalence of Fecal Carriage of Extended Spectrum bêta-lactamase Producing Enterobacteriaceae (ESBL) and Carbapenemase Producing Enterobacteriaceae (CPE) in Nursing Homes
CARBEHPAD is a multicentric randomized prevalence study aiming to assess the frequency of Enterobacteriaceae (ESLB) and carbapenemase producing Enterobacteriaceae (CPE) carriage in Pays de la Loire nursing homes.
A sample of 50 nursing homes (NH) in Pays de la Loire will be randomly selected for inclusion, and a sample of 1/3 of residents of these NH will be screened for ESBL and/or CPE fecal carriage. Epidemiological data on each resident will be collected to identify risk factors for such carriage.
Read the detailed description
The Pays de la Loire region is impacted by 2 main CPE outbreaks in the 2 major university hospitals in this region. A sample of 50 nursing homes (NH) in Pays de la Loire region (France) will be randomly selected for inclusion in CARBEHPAD study. NH directors will be contacted for agreement for inclusion in CARBEHPAD study. In each of the included NH, a sample of one third of residents will be randomly selected for inclusion. Upon agreement, each resident included will be screened through endorectal swabbing for ESBL and/or CPE carriage.
Epidemiological data will be collected for each resident regarding demographic data, risk factors for ESBL and/or CPE carriage, comorbidities. These data collected in the NH will be completed with data collection from national NH database regarding: previous hospitalization, treatments (including antibiotics), surgery.
Data on infection control and prevention will be collected in each NH to assess cross transmission of resistant bacteria in these settings.
Comparison of isolated strains will be performed to assess clonal dissemination of these resistant Enterobacteriaceae in NH. Data regarding infection control and prevention in each included NH will be collected aswell.
An ESBL/CPE carrier status has no impact on medical care in NH regarding French recommendations on management of such resistant microorganisms.
- Conditions
- Enterobacteriaceae Infections
- Keywords
- Carbapenemase, Enterobacteriaceae, extended spectrum beta-lactamases, nursing homes, prevalence
- Medical subject headings
- Enterobacteriaceae Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
carbapenemase producing Enterobacteriaceae (CPE) carriage
Assessment of CPE carriage through endorectal swabbing.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start3 Oct 2018
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterobacteriaceae InfectionsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 734 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel BIRGAND, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401242
- Sponsor's protocol ID
- RC17_0190
- Acronym
- CARBEHPAD
- Status last verified
- Apr 2019
- First submitted
- 3 Jan 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Prevalence of Fecal Carriage of Extended Spectrum bêta-lactamase Producing Enterobacteriaceae (ESBL) and Carbapenemase Producing Enterobacteriaceae (CPE) in Nursing Homes
- ClinicalTrials.gov ID
- NCT03401242
- Acronym / sponsor ID
- CARBEHPAD / RC17_0190
- Conditions
- Enterobacteriaceae Infections
- Keywords
- Carbapenemase, Enterobacteriaceae, extended spectrum beta-lactamases, nursing homes, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 734 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 17 Jan 2018 (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.
CARBEHPAD is a multicentric randomized prevalence study aiming to assess the frequency of Enterobacteriaceae (ESLB) and carbapenemase producing Enterobacteriaceae (CPE) carriage in Pays de la Loire nursing homes.
A sample of 50 nursing homes (NH) in Pays de la Loire will be randomly selected for inclusion, and a sample of 1/3 of residents of these NH will be screened for ESBL and/or CPE fecal carriage. Epidemiological data on each resident will be collected to identify risk factors for such carriage.
Detailed description
The Pays de la Loire region is impacted by 2 main CPE outbreaks in the 2 major university hospitals in this region. A sample of 50 nursing homes (NH) in Pays de la Loire region (France) will be randomly selected for inclusion in CARBEHPAD study. NH directors will be contacted for agreement for inclusion in CARBEHPAD study. In each of the included NH, a sample of one third of residents will be randomly selected for inclusion. Upon agreement, each resident included will be screened through endorectal swabbing for ESBL and/or CPE carriage.
Epidemiological data will be collected for each resident regarding demographic data, risk factors for ESBL and/or CPE carriage, comorbidities. These data collected in the NH will be completed with data collection from national NH database regarding: previous hospitalization, treatments (including antibiotics), surgery.
Data on infection control and prevention will be collected in each NH to assess cross transmission of resistant bacteria in these settings.
Comparison of isolated strains will be performed to assess clonal dissemination of these resistant Enterobacteriaceae in NH. Data regarding infection control and prevention in each included NH will be collected aswell.
An ESBL/CPE carrier status has no impact on medical care in NH regarding French recommendations on management of such resistant microorganisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 residents of the nursing homes of the 5 departments of Pays de la Loire will be included in this study protocol. Participants in the study will be randomly sampled according to a two-stage sampling design.
Key inclusion criteria (3 listed)
- Resident present in the nursing home on the day of the survey.
- Resident having agreed to be included in the study.
- Resident with a social security number.
Key exclusion criteria (1 listed)
- Resident non-compliant with sampling protocol.
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
carbapenemase producing Enterobacteriaceae (CPE) carriage
Time frame: six months
Assessment of CPE carriage through endorectal swabbing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
Gabriel BIRGAND, Dr principal investigator
Nantes University Hospital
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 Enterobacteriaceae Infections, run by Nantes University Hospital 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 16 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
carbapenemase producing Enterobacteriaceae (CPE) carriage (time frame: six months). 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 16 Apr 2019.