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OPTICUR-EBLSE: Optimization Management Study of Community Urinary Tract Infections Spectrum

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT03655548
Collaborator
(none)
108
Enrollment
4.9
Actual Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    108 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Oct 1, 2016
    Actual Primary Completion Date :
    Feb 28, 2017
    Actual Study Completion Date :
    Feb 28, 2017

    Outcome Measures

    Primary Outcome Measures

    1. percentage of adequation to ANSM 2015 guidelines of antibotics prescription for community acquired urinary tract infection before and after CBEU report [One month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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)

    Exclusion Criteria:

    • Children

    • Refusal of consent

    • CBEU prescribed by a specialist

    • patient hospitalised for management of the infection

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT03655548
    Other Study ID Numbers:
    • OPTICUR-EBLSE
    First Posted:
    Aug 31, 2018
    Last Update Posted:
    Aug 31, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Urinary Tract Infections
    Bacterial Infections
    Community-Acquired Infections

    Study Results

    No Results Posted as of Aug 31, 2018