Carbapenemase-Producing Organism and Vancomycin-Resistant Enterococcus Management (CPO-VRE)

August 4, 2023 updated by: University Hospital, Grenoble

Improving Carbapenemase-Producing Organism (CPO) and Vancomycin-Resistant Enterococcus (VRE) Management With BD Solutions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Carbapenemases, with versatile hydrolytic capacity against β-lactams, are now an important cause of resistance of Gram-negative bacteria. Furthermore, they are often resistant to a wide-range of antimicrobial agents The genes encoding for the acquired carbapenemases are associated with a high potential for dissemination. In addition, infections due to Gram-negative bacteria with acquired carbapenemase production would lead to high clinical mortality rates. These organisms often render standard empiric therapy ineffective. In fact, Zilberberg et al. demonstrated a higher rate of inappropriate empiric therapy leading to increased length of stay, mortality risk and hospital costs for carbapenem resistant organisms vs susceptible organisms.

The control of the VRE emergence became a priority to tackle the antibiotic resistance, fearing a transfer of the resistance to the methicillin-resistant Staphylococcus aureus (MRSA). VRE outbreaks were reported in CHUGA. Because of the high transmission potential, those VRE outbreaks had a substantial impact on the healthcare activity.

Hypothesis: 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.

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.

A before and after study design will be used. Investigators will compare the average turnaround time before and after the implementation of BD solutions.

Turnaround time is defined as time from sample collection to result delivered to the clinician and/or infection control team.

Result is defined as the detection of the major carbapenemase genes, including blaKPC, blaOXA-48, blaVIM and blaNDM genes or the detection of vanA gene associated to E. faecium identification from fecal swabs.

Study Type

Observational

Enrollment (Actual)

3921

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

  • France
      • Grenoble, France, 38043
        • Grenoble_Alpes UniversityHospital

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

Anybody coming in the CHUGA with at least one criteria of eXDR screening

Description

Inclusion Criteria:

Anybody coming in the CHUGA with at least one criteria of eXDR screening:

  • Hospitalized patients at least two times within the previous year
  • Patient transferred from another hospital
  • Patient transferred from nursing home
  • Patient with a history of hospitalization abroad (foreign countries) within the previous year
  • Contact patient = patient exposed to an eXDR bacteria carrier
  • eXDR carrier

Exclusion Criteria:

  • Refusal to participate to the study. Opposition of the patients to the use of their personal data.
  • Refusal of rectal swab

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
group "before"
1st period of 6 months during which only the current detection technique will be used.
group "after"
- 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of the BD CPO and VRE PCRs on the turnaround time for eXDR positive detection
Time Frame: 12 months

Compare the average turnaround time before and after the implementation of BD solutions.

Turnaround time is defined as time from sample collection to result delivered to the clinician and/or infection control team.

Result is defined as the detection of the major carbapenemase genes, including blaKPC, blaOXA-48, blaVIM and blaNDM genes or the detection of vanA gene associated to E. faecium identification from fecal swabs.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of the BD CPE and VRE PCR on the number of rectal screening performed by the laboratory
Time Frame: 12 months
Comparison before and after the implementation of BD solutions of the average number of rectal screening
12 months
turnaround time of removal of isolation measure
Time Frame: 12 months
In case of negative results, the turnaround time of removal of isolation measure for patients with a history of hospitalization abroad within the previous year will be determined.
12 months
number of patients in contact with eXDR patients
Time Frame: 12 months
In case of positive results, the average number of patients in contact with the eXDR carrier will be determined.
12 months
number of eXDR secondary cases
Time Frame: 12 months
The average number of secondary eXDR cases will be compared before and after the implementation of BD solutions.
12 months
number of day where the transfers and admissions are blocked for a medical unit
Time Frame: 12 months
The average number of day where the transfers and admissions are blocked for a medical unit will be compared before and after the implementation of BD solutions.
12 months
real cost of tests solutions
Time Frame: 12 months
The real cost of tests solutions, regarding to the amount of reimbursement by health insurance will be estimate.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Becton, Dickinson and Company

Investigators

  • Principal Investigator: Sandrine BOISSET, UGA, CHUGA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 18, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC21.0370
  • 2021-A02468-33 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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