Antibiotic ResistanceREASSENCT02367339
Assessment of the Prevalence of Extended-Spectrum Betalactamase Producing Enterobacteriaceae Among ICU Staff
An observational study of Antibiotic Resistance and Extended-spectrum Betalactamase, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Resistance, Extended-spectrum Betalactamase, Enterobacteriaceae
- What is being tested?
- ESBL
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to May 2016
- 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: ICU staff
Who may be able to join
- volunteers
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Julien PASCAL
About this study
Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff
Read the detailed description
Prospective epidemiological study with voluntary non-medical staff member (i.e. nurses and nursing assistants) and medical staff in two French ICUs.
Assessment of self-reported risk factors for MDR-bacteria colonization. Self-performed rectal swab with isolation of ESBL-producting Enterobacteriaceae, identification of bacterial species and antibiotic suspectibilities.
Characterization of Escherichia coli ESBL.
- Conditions
- Antibiotic Resistance, Extended-spectrum Betalactamase, Enterobacteriaceae, Escherichia Coli
- Being tested
- ESBL
- Keywords
- Critical Care, Nursing staff, Medical staff, Extended-spectrum betalactamase, Digestive tract colonization, Cross-contamination
- Medical subject headings
- Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESBLOther
Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff
What is being measured
The primary outcome is the main question the study is designed to answer.
Digestive tract colonization by ESBL
Digestive tract colonization by ESBL-producing Enterobacteriaceae on 1 faeces sample
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ResistanceStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Estaing, Hopital Gabriel Montpied
- Responsible party
- Sponsor
- Investigators
- Julien PASCAL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367339
- Sponsor's protocol ID
- CHU-0224
- Acronym
- REASSE
- Status last verified
- Feb 2015
- First submitted
- 12 Feb 2015
- Last updated
- 20 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence of Extended-Spectrum Betalactamase Producing Enterobacteriaceae Among ICU Staff
- ClinicalTrials.gov ID
- NCT02367339
- Acronym / sponsor ID
- REASSE / CHU-0224
- Conditions
- Antibiotic Resistance, Extended-spectrum Betalactamase, Enterobacteriaceae, Escherichia Coli
- Keywords
- Critical Care, Nursing staff, Medical staff, Extended-spectrum betalactamase, Digestive tract colonization, Cross-contamination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Estaing, Hopital Gabriel Montpied
- Study start
- Feb 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 20 Feb 2015 (estimated)
- 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.
Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff
Detailed description
Prospective epidemiological study with voluntary non-medical staff member (i.e. nurses and nursing assistants) and medical staff in two French ICUs.
Assessment of self-reported risk factors for MDR-bacteria colonization. Self-performed rectal swab with isolation of ESBL-producting Enterobacteriaceae, identification of bacterial species and antibiotic suspectibilities.
Characterization of Escherichia coli ESBL.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ICU staff
Key inclusion criteria (1 listed)
- volunteers
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ESBLEvaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff | Other | – |
Primary outcome
Digestive tract colonization by ESBL
Time frame: at day 1
Digestive tract colonization by ESBL-producing Enterobacteriaceae on 1 faeces sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
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Recruiting
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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.
Julien PASCAL principal investigator
University Hospital, Clermont-Ferrand
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 Antibiotic Resistance and Extended-spectrum Betalactamase, run by University Hospital, Clermont-Ferrand 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 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: status not confirmed, as of the sponsor's last update on 20 Feb 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digestive tract colonization by ESBL (time frame: at day 1). 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 20 Feb 2015.