Carbapenemase-Producing Organism and Vancomycin-Resistant Enterococcus Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multidrug-resistant Bacteria Screening

Intervention / Treatment
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* Diagnostic Test: molecular assays to screen for eXDR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group before<br>1st period of 6 months during which only the current detection technique will be used. | |
| group after<br>- 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<br>* 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.<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 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 | The real cost of tests solutions, regarding to the amount of reimbursement by health insurance will be estimate. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mutlidrug resistant bacteria, carbapenemase-producing enterobacteria, vancomycin-resistant enterococci, molecular assays