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

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 Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Community-Acquired Infections; Resistant Infection; Beta Lactam Resistant Bacterial Infection

• Study Type: Observational
• Enrollment (Actual): 108

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of adequation to ANSM 2015 guidelines of antibotics prescription for community acquired urinary tract infection before and after CBEU report	One month

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Urinary Tract Infections; Bacterial Infections; Community-Acquired Infections
• Other Study ID Numbers: OPTICUR-EBLSE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No