Drug Resistance, BacterialR'EHPADNCT03248999
Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes.
A study testing rectal swab in people with Drug Resistance, Bacterial, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistance, Bacterial
- What is being tested?
- rectal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2017to 26 Jun 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntary residents present in the institution on the study day
Who cannot join
- dement-wandering resident
- unlikely to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes in Franche-Comté (France).
This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.
Read the detailed description
Epimiological data concerning ESBL an CRE, may differ between nursing home and hospital or community but poor data are available.
Multi-drug resistant bacteria carriage is associated with individual and collective factors wich have to be defined in nursing homes.
- Conditions
- Drug Resistance, Bacterial
- Being tested
- rectal swab
- Keywords
- multidrug resistance, nursing home, ESBL, CRE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal swabDiagnostic test
stool samples by rectal swab
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | realization of a rectal swab or stool sample for all the résidents included in the study. Receives: Diagnostic Test: rectal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESBL and CRE carriage
number of residents colonized with a extented-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE)
Measured: the day of the study
Secondary outcomes (1)
patient and establishment factors associated with ESBL and CRE carriage with a questionnaire
evaluation of risk factors associated with ESBL and CRE carriage and disseminationwith a questionnaire.
Measured: the day of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start20 Nov 2017
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistance, BacterialStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline C Bouvier-Slekovec, Dr, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248999
- Sponsor's protocol ID
- P/2017/315
- Acronym
- R'EHPAD
- Status last verified
- Mar 2018
- First submitted
- 2 Aug 2017
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes in Franche-Comté (France).
- ClinicalTrials.gov ID
- NCT03248999
- Acronym / sponsor ID
- R'EHPAD / P/2017/315
- Conditions
- Drug Resistance, Bacterial
- Keywords
- multidrug resistance, nursing home, ESBL, CRE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 15 Aug 2017 (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.
This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.
Detailed description
Epimiological data concerning ESBL an CRE, may differ between nursing home and hospital or community but poor data are available.
Multi-drug resistant bacteria carriage is associated with individual and collective factors wich have to be defined in nursing homes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: rectal swabrealization of a rectal swab or stool sample for all the résidents included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- voluntary residents present in the institution on the study day
Key exclusion criteria (2 listed)
- dement-wandering resident
- unlikely to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rectal swabstool samples by rectal swab | Diagnostic test | Experimental |
Primary outcome
ESBL and CRE carriage
Time frame: the day of the study
number of residents colonized with a extented-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE)
1 secondary outcome
patient and establishment factors associated with ESBL and CRE carriage with a questionnaire
Time frame: the day of the study
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 6 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Céline C Bouvier-Slekovec, Dr principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rectal swab in people with Drug Resistance, Bacterial, run by Centre Hospitalier Universitaire de Besancon 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 1 inclusion and 2 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 6 Dec 2018. 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?
ESBL and CRE carriage (time frame: the day of the study). 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 6 Dec 2018.