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Completed

NCT Number: NCT05743192

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nancy University Hospital

Vandœuvre-lès-Nancy, 54511, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Stop performing an antibiotic susceptibility test

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

    Diagnosis = UTI or UCC

  7. 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Discontinuation of Antibiotic Susceptibility Testing on Monobacterial Enterococcus Faecalis Positive Urine Cultures: an Impact on Antibiotic Prescriptions?

Acronym: FaecaCible

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.