- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05743192
Discontinuation of Antibiotic Susceptibility Testing on Enterococcus Faecalis Positive Urine Cultures in Hospitalized Patients: an Impact on Antibiotic Prescriptions? (FaecaCible) (FaecaCible)
June 14, 2023 updated by: BARONNET Guillaume, Central Hospital, Nancy, France
Discontinuation of Antibiotic Susceptibility Testing on Monobacterial Enterococcus Faecalis Positive Urine Cultures: an Impact on Antibiotic Prescriptions?
The objective of the study is to evaluate the impact of not reporting antibiotic susceptibility tests on antibiotic consumption for Enterococcus faecalis positive urine cultures in adult hospitalized patients.
The secondary objectives are to evaluate the impact of this intervention on antibiotic prescription rates as well as on antibiotic consumption according to: patient gender, type of antibiotic therapy (probabilistic/documented) and diagnosis (urinary tract infection or colonization).
It is hypothesized that antibiotic consumption is lower after the application of the absence of antibiotic susceptibility reporting compared to before.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
217
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vandœuvre-lès-Nancy, France, 54511
- Nancy University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
These are urine cultures taken from 2nd urine stream, by urinary catheter or via a suprapubic catheter and with a positive culture for monomicrobial Enterococcus faecalis with a bacteriuria threshold greater than or equal to 10^3.
These urine cultures were performed between December 10, 2018 and December 10, 2020 in adults hospitalized at the Nancy University Hospital and present at least 72 hours after the validation of the antibiogram or the identification of the germ, excluding hospitalization or passage in hematology services, continuous care/intensive care, day hospitalization and consultation.
Description
Inclusion Criteria:
- Person having received complete information on the organization of the research and not having objected to the exploitation of these data
- Adult patients (More than 18);
- Having performed a urine culture at the Nancy University Hospital, taken from the 2nd urine stream, by urinary catheter or via a suprapubic catheter and whose culture is positive for monomicrobial E. faecalis with a bacteriuria threshold greater than or equal to 10^3 CFU/field;
- Hospitalized at the Nancy University Hospital at least 72 hours after validation of the antibiotic susceptibility test in the pre-intervention period and at least 72 hours after validation of the culture in the post-intervention period.
Exclusion Criteria:
- Inpatients in hematology, critical care/intensive care, consultation and day hospital units;
- Urine cultures performed in ambulatory units ;
- Urine culture performed in the critical care/intensive care/hematology units;
- Patients discharged from hospital/deceased/transferred to intensive care within 72 hours of the validation of the antibiotic susceptibility test or the validation of the urine culture;
- Patients with associated E. faecalis bacteremia;
- Urine culture without an antibiotic susceptibility test for the pre-intervention period;
- Urine culture with a monomicrobial history of less than 1 week;
- Culture of urine from pyelic punctures or nephrostomy tubes - conservation of those from second streams, urinary catheters and suprapubic catheters).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Before group
Group of patients with a positive urine culture for Enterococcus faecalis before the procedure consisting of systematically performing an antibiotic susceptibility test.
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After group
Group of patients with a positive urine culture for Enterococcus faecalis after the procedure consisting of systematically performing an antibiotic susceptibility test.
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Intervention = Stop performing an antibiotic susceptibility test for enterococcus faecalis in urine cultures.
It defines two groups : one before and one after the intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of positive urine culture for which antibiotic therapy was prescribed (%)
Time Frame: Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prescription rate of each antibiotic class/molecule (%)
Time Frame: Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
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Proportion of urine cultures for which antibiotic therapy was prescribed (%) by type of antibiotic therapy.
Time Frame: Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
Type of antibiotic therapy = probabilistic or documented
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Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
|
Prescription rate of each antibiotic class/molecule (%) by type of antibiotic therapy.
Time Frame: Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
|
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Proportion of urine cultures for which antibiotic therapy was prescribed (%) by sex of patient
Time Frame: Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
|
|
Prescription rate of each antibiotic class/molecule (%) by patient gender
Time Frame: Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
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Proportion of urine cultures for which antibiotic therapy was prescribed (%) by diagnosis
Time Frame: Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
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Diagnosis = UTI or UCC
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Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
|
Prescription rate of each antibiotic class/molecule (%) by diagnosis
Time Frame: Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
Diagnosis = UTI or UCC
|
Between 24 hours before the urine culture is collected and 72 hours following the validation of the antibiotic susceptibility test/the urine culture by the biologist
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2023
Primary Completion (Actual)
June 8, 2023
Study Completion (Actual)
June 8, 2023
Study Registration Dates
First Submitted
February 15, 2023
First Submitted That Met QC Criteria
February 15, 2023
First Posted (Actual)
February 24, 2023
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 14, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022PI075
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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