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Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia and Fungemia. (HEMOFAST)

Primary Purpose

Bacteremia Sepsis, Fungemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multiplex PCR
Current strategy alone
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bacteremia Sepsis focused on measuring multiplex PCR, blood culture, rapid diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with bacteremia and/or fungemia defined by :

    1/ the presence of clinical signs of sepsis; AND 2/ a positive blood culture, i.e. the growth of at least one species of bacteria or micromyces in at least one blood culture vial

  • Patient Hospitalized at Grenoble University Hospital (only North site) and seen by a physician from the antibiotic stewardship team
  • First blood culture positive for the patient's sepsis episode
  • Informed and written consent signed by the patient or his legal representative or the doctor in case of emergency.

Exclusion Criteria:

  • Patients mentioned in the law articles L1121-5 to L1121-8 from French Health Code
  • Patients hospitalized in palliative care unit
  • Persons with an estimated survival of less than one month

Sites / Locations

  • Grenoble University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multiplex PCR + Current strategy

Current strategy alone

Arm Description

Results of the multiplex PCR will be send as soon as possible to the infectious disease phycian for quick adaptation of antibiotic treatment. Positive blood cultures will also undergo current diagnosis strategy for bacteremia and fungemia.

Current diagnostic strategy based on the identification of bacteria and micromyces isolated in blood cultures after subculture by mass spectrometry (MALDI-TOF) and determination of their sensitivity to antibiotics or antifungals by antibiotic susceptibility testing or antifungigram

Outcomes

Primary Outcome Measures

Delay from suspicion of sepsis to optimized antibiotic/antifungal treatment
Delay between first sampling of blood cultures for sepsis and optimized antibiotic/antifungal treatment. Treatment will be considered optimized if it is active on the bacteria/fungi responsible for sepsis and if it follows current treatment recommendations for the bacteria/fungi identified.

Secondary Outcome Measures

Medical evaluation of the consequences of the innovative strategy compared to current strategy : 30-day mortality
The following clinical consequences will be measured and compared in each arm : 30-day mortality
Medical evaluation of the consequences of the innovative strategy compared to current strategy : complication rate
The following clinical consequences will be measured and compared in each arm : complication rate (ICU admission or length of stay, antibiotic/antifungal treatment toxicity rate, recurrence of sepsis within 30 days, re-admission to hospital within 30 days)
Medical evaluation of the consequences of the innovative strategy compared to current strategy : length of hospital stay
The following clinical consequences will be measured and compared in each arm : length of hospital stay
Medical evaluation of the consequences of the innovative strategy compared to current strategy : antibiotic treatment duration
The following clinical consequences will be measured and compared in each arm : treatment duration for antibiotics with high impact on the commensal flora (i.e. : carbapenems) or with high toxicity (i.e. : vancomycin)
Medical evaluation of the consequences of the innovative strategy compared to current strategy : delay of antibiotic/antifungal treatment modification at several time points
The following clinical consequences will be measured and compared in each arm : delay of antibiotic/antifungal treatment modification at several time points (after the result of the Gram stain, after the results of the multiplex PCR, after the results of the identification of the bacteria/fungi and after the results of antibiotic/antifungal treatment susceptibility).
Medical evaluation of the consequences of the innovative strategy compared to current strategy : rate of antibiotic/antifungal treatment modification at several time points
The following clinical consequences will be measured and compared in each arm : rate of antibiotic/antifungal treatment modification at several time points (after the result of the Gram stain, after the results of the multiplex PCR, after the results of the identification of the bacteria/fungi and after the results of antibiotic/antifungal treatment susceptibility).
Economic evaluation of the hospitalization costs of the innovative strategy compared to current strategy
Hospitalization costs will be measured
Economic evaluation of the treatments costs of the innovative strategy compared to current strategy
Anti-infectious treatment costs will be measured
Economic evaluation of the costs of the innovative compared to current strategy
Costs of the innovative assay (reagents and device) will be measured
Economic evaluation of the medical imaging costs of the innovative strategy compared to current strategy
Medical imaging costs will be measured
Economic impact of the introduction of the innovative strategy for Grenoble University Hospital
Measurement and evaluation of the economic impact of the innovative strategy on the budget of Grenoble University Hospital, on the target population, for a period of one year.

Full Information

First Posted
March 11, 2019
Last Updated
October 26, 2021
Sponsor
University Hospital, Grenoble
Collaborators
GenMark Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT03876990
Brief Title
Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia and Fungemia.
Acronym
HEMOFAST
Official Title
Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia or Fungemia From Positive Blood Culture Bottles, Combining Fast Identification of Bacteria and Fungi and Evaluation of Bacterial Resistance to First Line Antibiotics.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
GenMark Diagnostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the clinical benefit of a rapid test for fast diagnosis of bacteremia and fungemia from positive blood cultures in case of sepsis. This assay enables rapid identification of bacteria and fungi and allows to evaluate bacterial resistance to first line antibiotics. The clinical and medico-economic impact of this assay used in addition to the current diagnosis strategy (half of the patients) will be compared to the current diagnostic strategy alone (other half of the patient).
Detailed Description
Bacteremia and fungemia are severe complications, sometimes life-threatening, of every sepsis. During septicemia, every hour matters to start an appropriate antibiotic or antifungal treatment as every hour of delay is associated to higher death rate. The rapid multiplex PCR assay that is evaluated in this study allows to identify in 60 to 90 minutes, the bacteria or fungi that is present in the positive blood culture bottles and to identify resistance markers to first line antibiotics that are used to treat sepsis. This strategy allows quicker adaptation of antibacterial or antifungal treatment based on the species of the bacteria or fungi identified and on the results of the resistance markers compared to current diagnosis strategy of bacteremia or fungemia. This quicker adaptation could lead to improved survival rate, reduced complications of sepsis, reduced hospital stay length and could reduce the use of large spectrum antibiotics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia Sepsis, Fungemia
Keywords
multiplex PCR, blood culture, rapid diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized assignation. Half of the patients will be diagnosed by the rapid test in addition to current diagnosis strategy and the other half by current diagnosis strategy alone.
Masking
Participant
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiplex PCR + Current strategy
Arm Type
Experimental
Arm Description
Results of the multiplex PCR will be send as soon as possible to the infectious disease phycian for quick adaptation of antibiotic treatment. Positive blood cultures will also undergo current diagnosis strategy for bacteremia and fungemia.
Arm Title
Current strategy alone
Arm Type
Active Comparator
Arm Description
Current diagnostic strategy based on the identification of bacteria and micromyces isolated in blood cultures after subculture by mass spectrometry (MALDI-TOF) and determination of their sensitivity to antibiotics or antifungals by antibiotic susceptibility testing or antifungigram
Intervention Type
Diagnostic Test
Intervention Name(s)
Multiplex PCR
Intervention Description
Quick adaptation of antibiotic treatment according to the species identified and to the results of the resistance markers present in the multiplex PCR
Intervention Type
Diagnostic Test
Intervention Name(s)
Current strategy alone
Other Intervention Name(s)
MALDI-TOFF identification
Intervention Description
Identification of bacteria and micromyces isolated in blood cultures after subculture by mass spectrometry (MALDI-TOF) and determination of their sensitivity to antibiotics or antifungals by antibiotic susceptibility testing or antifungigram
Primary Outcome Measure Information:
Title
Delay from suspicion of sepsis to optimized antibiotic/antifungal treatment
Description
Delay between first sampling of blood cultures for sepsis and optimized antibiotic/antifungal treatment. Treatment will be considered optimized if it is active on the bacteria/fungi responsible for sepsis and if it follows current treatment recommendations for the bacteria/fungi identified.
Time Frame
Follow up is set to hospital length stay with a maximum of 30 days
Secondary Outcome Measure Information:
Title
Medical evaluation of the consequences of the innovative strategy compared to current strategy : 30-day mortality
Description
The following clinical consequences will be measured and compared in each arm : 30-day mortality
Time Frame
Hospital length stay with a maximum of 30 days
Title
Medical evaluation of the consequences of the innovative strategy compared to current strategy : complication rate
Description
The following clinical consequences will be measured and compared in each arm : complication rate (ICU admission or length of stay, antibiotic/antifungal treatment toxicity rate, recurrence of sepsis within 30 days, re-admission to hospital within 30 days)
Time Frame
Hospital length stay with a maximum of 30 days
Title
Medical evaluation of the consequences of the innovative strategy compared to current strategy : length of hospital stay
Description
The following clinical consequences will be measured and compared in each arm : length of hospital stay
Time Frame
Hospital length stay with a maximum of 30 days
Title
Medical evaluation of the consequences of the innovative strategy compared to current strategy : antibiotic treatment duration
Description
The following clinical consequences will be measured and compared in each arm : treatment duration for antibiotics with high impact on the commensal flora (i.e. : carbapenems) or with high toxicity (i.e. : vancomycin)
Time Frame
Hospital length stay with a maximum of 30 days
Title
Medical evaluation of the consequences of the innovative strategy compared to current strategy : delay of antibiotic/antifungal treatment modification at several time points
Description
The following clinical consequences will be measured and compared in each arm : delay of antibiotic/antifungal treatment modification at several time points (after the result of the Gram stain, after the results of the multiplex PCR, after the results of the identification of the bacteria/fungi and after the results of antibiotic/antifungal treatment susceptibility).
Time Frame
Hospital length stay with a maximum of 30 days
Title
Medical evaluation of the consequences of the innovative strategy compared to current strategy : rate of antibiotic/antifungal treatment modification at several time points
Description
The following clinical consequences will be measured and compared in each arm : rate of antibiotic/antifungal treatment modification at several time points (after the result of the Gram stain, after the results of the multiplex PCR, after the results of the identification of the bacteria/fungi and after the results of antibiotic/antifungal treatment susceptibility).
Time Frame
Hospital length stay with a maximum of 30 days
Title
Economic evaluation of the hospitalization costs of the innovative strategy compared to current strategy
Description
Hospitalization costs will be measured
Time Frame
Hospital length stay with a maximum of 30 days
Title
Economic evaluation of the treatments costs of the innovative strategy compared to current strategy
Description
Anti-infectious treatment costs will be measured
Time Frame
Hospital length stay with a maximum of 30 days
Title
Economic evaluation of the costs of the innovative compared to current strategy
Description
Costs of the innovative assay (reagents and device) will be measured
Time Frame
Hospital length stay with a maximum of 30 days
Title
Economic evaluation of the medical imaging costs of the innovative strategy compared to current strategy
Description
Medical imaging costs will be measured
Time Frame
Hospital length stay with a maximum of 30 days
Title
Economic impact of the introduction of the innovative strategy for Grenoble University Hospital
Description
Measurement and evaluation of the economic impact of the innovative strategy on the budget of Grenoble University Hospital, on the target population, for a period of one year.
Time Frame
Extrapolation of the costs for a one year period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with bacteremia and/or fungemia defined by : 1/ the presence of clinical signs of sepsis; AND 2/ a positive blood culture, i.e. the growth of at least one species of bacteria or micromyces in at least one blood culture vial Patient Hospitalized at Grenoble University Hospital (only North site) and seen by a physician from the antibiotic stewardship team First blood culture positive for the patient's sepsis episode Informed and written consent signed by the patient or his legal representative or the doctor in case of emergency. Exclusion Criteria: Patients mentioned in the law articles L1121-5 to L1121-8 from French Health Code Patients hospitalized in palliative care unit Persons with an estimated survival of less than one month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvan CASPAR, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30487304
Citation
Huang TD, Melnik E, Bogaerts P, Evrard S, Glupczynski Y. Evaluation of the ePlex Blood Culture Identification Panels for Detection of Pathogens in Bloodstream Infections. J Clin Microbiol. 2019 Jan 30;57(2):e01597-18. doi: 10.1128/JCM.01597-18. Print 2019 Feb.
Results Reference
background
PubMed Identifier
26197846
Citation
Banerjee R, Teng CB, Cunningham SA, Ihde SM, Steckelberg JM, Moriarty JP, Shah ND, Mandrekar JN, Patel R. Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing. Clin Infect Dis. 2015 Oct 1;61(7):1071-80. doi: 10.1093/cid/civ447. Epub 2015 Jul 20.
Results Reference
background
PubMed Identifier
16625125
Citation
Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96. doi: 10.1097/01.CCM.0000217961.75225.E9.
Results Reference
background
PubMed Identifier
27795335
Citation
Patel TS, Kaakeh R, Nagel JL, Newton DW, Stevenson JG. Cost Analysis of Implementing Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry Plus Real-Time Antimicrobial Stewardship Intervention for Bloodstream Infections. J Clin Microbiol. 2016 Dec 28;55(1):60-67. doi: 10.1128/JCM.01452-16. Print 2017 Jan.
Results Reference
background
PubMed Identifier
29284316
Citation
Maubon D, Dard C, Garnaud C, Cornet M. Profile of GenMark's ePlex(R) blood culture identification fungal pathogen panel. Expert Rev Mol Diagn. 2018 Feb;18(2):119-132. doi: 10.1080/14737159.2018.1420476. Epub 2017 Dec 28.
Results Reference
background
PubMed Identifier
27678085
Citation
Timbrook TT, Morton JB, McConeghy KW, Caffrey AR, Mylonakis E, LaPlante KL. The Effect of Molecular Rapid Diagnostic Testing on Clinical Outcomes in Bloodstream Infections: A Systematic Review and Meta-analysis. Clin Infect Dis. 2017 Jan 1;64(1):15-23. doi: 10.1093/cid/ciw649. Epub 2016 Sep 26.
Results Reference
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Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia and Fungemia.

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