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Carbapenemase-Producing Organism and Vancomycin-Resistant Enterococcus Management

NCT05200546 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3921

Last updated 2023-08-07

No results posted yet for this study

Summary

Emergence of vancomycin-resistant enterococci (VRE) and carbapenemase-producing enterobacteria (CPE) is nowadays a major public health concern worldwide. VRE and CPE are referred to as Emerging eXtensively Drug Resistant bacteria (eXDR).

A better, faster and more accurate identification of VRE and CPE would allow faster appropriate therapy for patients and/or infection control strategies. Faster appropriate therapy could improve mortality rates, length of stay, and other patient outcomes as well as hospital costs. BD offers a variety of products, services and solutions designed to increase efficiency, streamline processes, and deliver high quality and consistent results with improved turnaround time.

The primary objective of this study will be to measure the impact of the BD CPO and VRE PCRs on the turnaround time for eXDR positive detection.

Study will collect criteria and compared several outcomes before and after the implementation of the BD solutions for the detection of eXDR.

This is a non-interventional research with a before/after design.

The study therefore consists of two periods:

* 1st period of 6 months during which only the current detection technique will be used.
* 2nd period of 6 months after implementation of the PCR solution (CPO and VRE) of the BD company in parallel with the usual screening technique.

Advantages of using molecular assays to screen for eXDR include labor savings, faster turnaround time, and higher sensitivity than culture-based methods.

In trying to reduce testing time, investigators should have better control of the eXDR transmission. this should reduce patient-to-patient transmissions. The number of contact patient in case of one positive screening should decrease. The number of days where patients are unnecessary placed in preemptive isolation should also decrease.

Moreover, PCR will be use in first intention and only positive samples in PCR will be cultivated; For the laboratory, technician time saving is expected given the simplicity of the PCRs. Plate readings at 24 and 48h will be limited to a few samples. Investigators also expect a significant gain in financial terms for hospital by performing a medico-economic analysis. According to the shorter time for getting results using BD solution in diagnosing patients at risk, investigators then assume that a shorter time in making clinical decision will be a normal consequence, and will imply a better relevant organization of care with lower real costs.

Conditions

  • Multidrug-resistant Bacteria Screening

Interventions

DIAGNOSTIC_TEST

molecular assays to screen for eXDR

VRE detection will be performed using "VIASURE Vancomycin resistance Real Time PCR Detection Kit". BD MAX Check-Points CPO will be used to detect carbapenemase-producing organisms.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    collaborator INDUSTRY

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Sandrine BOISSET · UGA, CHUGA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-18
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05200546 on ClinicalTrials.gov