Multidrug-resistant Bacteria ScreeningCPO-VRENCT05200546
Carbapenemase-Producing Organism and Vancomycin-Resistant Enterococcus Management
An observational study of Multidrug-resistant Bacteria Screening, run by University Hospital, Grenoble at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multidrug-resistant Bacteria Screening
- What is being tested?
- molecular assays to screen for eXDR
- How many people
- 3,921 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Anybody coming in the CHUGA with at least one criteria of eXDR screening
Who may be able to join
- 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
Who cannot join
- Refusal to participate to the study. Opposition of the patients to the use of their personal data.
- Refusal of rectal swab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Multidrug-resistant Bacteria Screening
- Being tested
- molecular assays to screen for eXDR
- Keywords
- mutlidrug resistant bacteria, carbapenemase-producing enterobacteria, vancomycin-resistant enterococci, molecular assays
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular assays to screen for eXDRDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: molecular assays to screen for eXDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start18 Feb 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multidrug-resistant Bacteria ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,921 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Sponsor
- Investigators
- Sandrine BOISSET, Principal investigator, UGA, CHUGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200546
- Sponsor's protocol ID
- 38RC21.0370
- Other IDs
- 2021-A02468-33
- Acronym
- CPO-VRE
- Status last verified
- Aug 2023
- First submitted
- 6 Jan 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25412897Bilavsky 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.
PubMed 20581673Zilberberg 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.
PubMed 29225798Lepelletier 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.
PubMed 25986165Mak 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.
PubMed 19846635Holzknecht 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.
PubMed 28203378
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Carbapenemase-Producing Organism (CPO) and Vancomycin-Resistant Enterococcus (VRE) Management With BD Solutions
- ClinicalTrials.gov ID
- NCT05200546
- Acronym / sponsor ID
- CPO-VRE / 38RC21.0370
- Conditions
- Multidrug-resistant Bacteria Screening
- Keywords
- mutlidrug resistant bacteria, carbapenemase-producing enterobacteria, vancomycin-resistant enterococci, molecular assays
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,921 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group "before" | – | –1st period of 6 months during which only the current detection technique will be used. |
| group "after" | – | Diagnostic Test: molecular assays to screen for eXDR- 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anybody coming in the CHUGA with at least one criteria of eXDR screening
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to participate to the study. Opposition of the patients to the use of their personal data.
- Refusal of rectal swab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular assays to screen for eXDRVRE 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. | Diagnostic test | group "after" |
Primary outcome
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.
6 secondary outcomes
impact of the BD CPE and VRE PCR on the number of rectal screening performed by the laboratory
Time frame: 12 months
turnaround time of removal of isolation measure
Time frame: 12 months
number of patients in contact with eXDR patients
Time frame: 12 months
number of eXDR secondary cases
Time frame: 12 months
number of day where the transfers and admissions are blocked for a medical unit
Time frame: 12 months
real cost of tests solutions
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Background: PubMed 25412897Zilberberg 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.
- Background: PubMed 20581673Bilavsky 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.
- Background: PubMed 29225798Zilberberg 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.
- Background: PubMed 25986165Lepelletier 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.
- Background: PubMed 19846635Mak 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.
- Background: PubMed 28203378Holzknecht 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine BOISSET principal investigator
UGA, CHUGA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multidrug-resistant Bacteria Screening, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of the BD CPO and VRE PCRs on the turnaround time for eXDR positive detection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05200546, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.