Optimization Management Study of Community Urinary Tract Infections Spectrum

NCT03655548 | Completed

• 1 other identifier: OPTICUR-EBLSE
• Study Type: observational
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Tract Infections; Resistant Infection; Community-Acquired Infections; Beta Lactam Resistant Bacterial Infection

Outcome Measures

Primary Outcomes (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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• CBEU analyzed by Labazur laboratory
• CBEU positive for a spectrum β-lactamase-producing Enterobacteriaceae (ESBLE)

You may not qualify if:

• Children
• Refusal of consent
• CBEU prescribed by a specialist
• patient hospitalised for management of the infection

Sponsors & Collaborators

• University Hospital, Brest: lead

MeSH Terms

Conditions

Urinary Tract Infections; Community-Acquired Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2016
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08