Optimization Management Study of Community Urinary Tract Infections Spectrum

Urinary Tract Infections Clinical Trial

— OPTICUR-EBLSE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655548
• Other study ID #: OPTICUR-EBLSE
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: August 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-lactamase-producing Enterobacteriaceae (ESBLE)

Exclusion Criteria:

• Children

• Refusal of consent

• CBEU prescribed by a specialist

• patient hospitalised for management of the infection

Related Conditions & MeSH terms

• Bacterial Infections
• Beta Lactam Resistant Bacterial Infection
• Communicable Diseases
• Community-Acquired Infections
• Infection
• Resistant Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of adequation to ANSM 2015 guidelines of antibotics prescription for community acquired urinary tract infection before and after CBEU report		One month