Carbapenemase-Producing Organism and Vancomycin-Resistant Enterococcus Management

NCT05200546 | Completed

• 2 other identifiers: 38RC21.03702021-A02468-33
• Study Type: observational
• Target: 3,921
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mutlidrug resistant bacteria; carbapenemase-producing enterobacteria; vancomycin-resistant enterococci; molecular assays

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• impact of the BD CPE and VRE PCR on the number of rectal screening performed by the laboratory

  12 months

• turnaround time of removal of isolation measure

  12 months

• number of patients in contact with eXDR patients

  12 months

• number of eXDR secondary cases

  12 months

• number of day where the transfers and admissions are blocked for a medical unit

  12 months

Study Arms (2)

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

Interventions

molecular assays to screen for eXDR DIAGNOSTIC_TEST

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.

group "after"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Becton, Dickinson and Company: collaborator

Study Sites (1)

Grenoble_Alpes UniversityHospital

Grenoble, 38043, France

Location

Related Publications (6)

• Zilberberg MD, Shorr AF, Micek ST, Vazquez-Guillamet C, Kollef MH. Multi-drug resistance, inappropriate initial antibiotic therapy and mortality in Gram-negative severe sepsis and septic shock: a retrospective cohort study. Crit Care. 2014 Nov 21;18(6):596. doi: 10.1186/s13054-014-0596-8.

  PMID: 25412897 BACKGROUND

• Bilavsky E, Schwaber MJ, Carmeli Y. How to stem the tide of carbapenemase-producing enterobacteriaceae?: proactive versus reactive strategies. Curr Opin Infect Dis. 2010 Aug;23(4):327-31. doi: 10.1097/QCO.0b013e32833b3571.

  PMID: 20581673 BACKGROUND

• Zilberberg MD, Nathanson BH, Sulham K, Fan W, Shorr AF. 30-day readmission, antibiotics costs and costs of delay to adequate treatment of Enterobacteriaceae UTI, pneumonia, and sepsis: a retrospective cohort study. Antimicrob Resist Infect Control. 2017 Dec 6;6:124. doi: 10.1186/s13756-017-0286-9. eCollection 2017.

  PMID: 29225798 BACKGROUND

• Lepelletier D, Berthelot P, Lucet JC, Fournier S, Jarlier V, Grandbastien B; National Working Group. French recommendations for the prevention of 'emerging extensively drug-resistant bacteria' (eXDR) cross-transmission. J Hosp Infect. 2015 Jul;90(3):186-95. doi: 10.1016/j.jhin.2015.04.002. Epub 2015 Apr 24.

  PMID: 25986165 BACKGROUND

• Mak A, Miller MA, Chong G, Monczak Y. Comparison of PCR and culture for screening of vancomycin-resistant Enterococci: highly disparate results for vanA and vanB. J Clin Microbiol. 2009 Dec;47(12):4136-7. doi: 10.1128/JCM.01547-09. Epub 2009 Oct 21.

  PMID: 19846635 BACKGROUND

• Holzknecht BJ, Hansen DS, Nielsen L, Kailow A, Jarlov JO. Screening for vancomycin-resistant enterococci with Xpert(R) vanA/vanB: diagnostic accuracy and impact on infection control decision making. New Microbes New Infect. 2017 Jan 12;16:54-59. doi: 10.1016/j.nmni.2016.12.020. eCollection 2017 Mar.

  PMID: 28203378 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

rectal swabs

Study Officials

• Sandrine BOISSET

  UGA, CHUGA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: February 18, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)