Urinary Tract InfectionsOPTICUR-EBLSENCT03655548
Optimization Management Study of Community Urinary Tract Infections Spectrum
An observational study of Urinary Tract Infections and Resistant Infection, run by University Hospital, Brest.
Trial summary
Urinary tract infections are the second most common community-acquired infections. Even if extended spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) cause fewer urinary tract infections, their proportion is increasing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Resistant Infection, Community-Acquired Infections
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 28 Feb 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient who were prescribed by a GP a CBEU during the 2 inclusion periods (from 1/10/2016 to 28/02/2017 with a first period from 01/10/2016 to 30/11/2016 and a second period from 02/01/2016 to 28/02/2017) * CBEU analyzed by Labazur laboratory * CBEU positive for a spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) * Ambulatory management of the infection by the GP
Who may be able to join
- Adult patient who were prescribed by a GP a CBEU during the 2 inclusion periods (from 1/10/2016 to 28/02/2017 with a first period from 01/10/2016 to 30/11/2016 and a second period from 02/01/2016 to 28/02/2017)
- CBEU analyzed by Labazur laboratory
- CBEU positive for a spectrum β-lactamase-producing Enterobacteriaceae (ESBLE)
Who cannot join
- Children
- Refusal of consent
- CBEU prescribed by a specialist
- patient hospitalised for management of the infection
About this study
Urinary tract infections are the second most common community-acquired infections. Even if extended spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) cause fewer urinary tract infections, their proportion is increasing. New recommendations were published by ANSM in 2015, with specific recommendations for infections due to ESBL-producing Enterobacteriaceae. In this study, we wanted to evaluate the effectiveness of a recall of the 2015 recommendations in the form of a table attached to the ECBU report, associated with hygiene recommendations.
Methodology: This prospective, multi-center, non-interventional study was conducted in collaboration with the Labazur laboratory over two 2-month periods, one without modification of the laboratory's practices, the other with the addition of documents on the CBEU report. The primary endpoint was the adequacy of prescriptions to ANSM 2015 recommendations.
- Conditions
- Urinary Tract Infections, Resistant Infection, Community-Acquired Infections, Beta Lactam Resistant Bacterial Infection
- Medical subject headings
- Urinary Tract Infections, Community-Acquired Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of adequation to ANSM 2015 guidelines of antibotics prescription for community acquired urinary tract infection before and after CBEU report
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Oct 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655548
- Sponsor's protocol ID
- OPTICUR-EBLSE
- Acronym
- OPTICUR-EBLSE
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 31 Aug 2018
- 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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization Management Study of Community Urinary Tract Infections Spectrum
- ClinicalTrials.gov ID
- NCT03655548
- Acronym / sponsor ID
- OPTICUR-EBLSE / OPTICUR-EBLSE
- Conditions
- Urinary Tract Infections, Resistant Infection, Community-Acquired Infections, Beta Lactam Resistant Bacterial Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 31 Aug 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.
Urinary tract infections are the second most common community-acquired infections. Even if extended spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) cause fewer urinary tract infections, their proportion is increasing. New recommendations were published by ANSM in 2015, with specific recommendations for infections due to ESBL-producing Enterobacteriaceae. In this study, we wanted to evaluate the effectiveness of a recall of the 2015 recommendations in the form of a table attached to the ECBU report, associated with hygiene recommendations.
Methodology: This prospective, multi-center, non-interventional study was conducted in collaboration with the Labazur laboratory over two 2-month periods, one without modification of the laboratory's practices, the other with the addition of documents on the CBEU report. The primary endpoint was the adequacy of prescriptions to ANSM 2015 recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient who were prescribed by a GP a CBEU during the 2 inclusion periods (from 1/10/2016 to 28/02/2017 with a first period from 01/10/2016 to 30/11/2016 and a second period from 02/01/2016 to 28/02/2017) * CBEU analyzed by Labazur laboratory * CBEU positive for a spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) * Ambulatory management of the infection by the GP
Key inclusion criteria (3 listed)
- Adult patient who were prescribed by a GP a CBEU during the 2 inclusion periods (from 1/10/2016 to 28/02/2017 with a first period from 01/10/2016 to 30/11/2016 and a second period from 02/01/2016 to 28/02/2017)
- CBEU analyzed by Labazur laboratory
- CBEU positive for a spectrum β-lactamase-producing Enterobacteriaceae (ESBLE)
Key exclusion criteria (4 listed)
- Children
- Refusal of consent
- CBEU prescribed by a specialist
- patient hospitalised for management of the infection
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
percentage of adequation to ANSM 2015 guidelines of antibotics prescription for community acquired urinary tract infection before and after CBEU report
Time frame: One month
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 31 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections and Resistant Infection, run by University Hospital, Brest.
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 4 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
percentage of adequation to ANSM 2015 guidelines of antibotics prescription for community acquired urinary tract infection before and after CBEU report (time frame: One month). 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 31 Aug 2018.