Antibiotic Susceptibility ReportingFaecaCibleNCT05743192

Discontinuation of Antibiotic Susceptibility Testing on Enterococcus Faecalis Positive Urine Cultures in Hospitalized Patients: an Impact on Antibiotic Prescriptions? (FaecaCible)

An observational study of Antibiotic Susceptibility Reporting, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Antibiotic Susceptibility Reporting
What is being tested?: Stop performing an antibiotic susceptibility test
How many people: 217 participants
Where: 1 siteFrance
Study dates: 15 Feb 2023to 8 Jun 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

France1 site

Nancy University Hospital
Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: 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.

Conditions: Antibiotic Susceptibility Reporting
Being tested: Stop performing an antibiotic susceptibility test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stop performing an antibiotic susceptibility testOther
Intervention = Stop performing an antibiotic susceptibility test for enterococcus faecalis in urine cultures. It defines two groups : one before and one after the intervention

Study groups in NCT05743192
Study group	Role	What they receive
Before group		Group of patients with a positive urine culture for Enterococcus faecalis before the procedure consisting of systematically performing an antibiotic susceptibility test.
After group		Group of patients with a positive urine culture for Enterococcus faecalis after the procedure consisting of systematically performing an antibiotic susceptibility test. Receives: Other: Stop performing an antibiotic susceptibility test

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of positive urine culture for which antibiotic therapy was prescribed (%)
Measured: 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

Secondary outcomes (7)

Prescription rate of each antibiotic class/molecule (%)
Measured: 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
Proportion of urine cultures for which antibiotic therapy was prescribed (%) by type of antibiotic therapy.
Type of antibiotic therapy = probabilistic or documented
Measured: 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.
Measured: 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
Proportion of urine cultures for which antibiotic therapy was prescribed (%) by sex of patient
Measured: 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
Measured: 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
Proportion of urine cultures for which antibiotic therapy was prescribed (%) by diagnosis
Diagnosis = UTI or UCC
Measured: 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
Diagnosis = UTI or UCC
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 20238 Jun 2023

First posted24 Feb 2023
Study start15 Feb 2023
Primary completion8 Jun 2023
Study completion8 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Antibiotic Susceptibility ReportingStudies of the same condition, open and under way.
More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05743192
Sponsor's protocol ID: 2022PI075
Acronym: FaecaCible
Status last verified: Jun 2023
First submitted: 15 Feb 2023
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Discontinuation of Antibiotic Susceptibility Testing on Monobacterial Enterococcus Faecalis Positive Urine Cultures: an Impact on Antibiotic Prescriptions?
ClinicalTrials.gov ID: NCT05743192
Acronym / sponsor ID: FaecaCible / 2022PI075
Conditions: Antibiotic Susceptibility Reporting
Study type: Observational
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: Central Hospital, Nancy, FranceUniversity, hospital or other
Study start: 15 Feb 2023 (actual)
Primary completion: 8 Jun 2023 (actual)
Study completion: 8 Jun 2023 (actual)
First posted: 24 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Before group	–	–Group of patients with a positive urine culture for Enterococcus faecalis before the procedure consisting of systematically performing an antibiotic susceptibility test.
After group	–	Other: Stop performing an antibiotic susceptibility testGroup of patients with a positive urine culture for Enterococcus faecalis after the procedure consisting of systematically performing an antibiotic susceptibility test.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stop performing an antibiotic susceptibility testIntervention = Stop performing an antibiotic susceptibility test for enterococcus faecalis in urine cultures. It defines two groups : one before and one after the intervention	Other	After group

Primary outcome

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

7 secondary outcomes

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
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
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Antibiotic Susceptibility Reporting, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05743192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.