Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia and Fungemia.
NCT ID: NCT03876990
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
312 participants
INTERVENTIONAL
2019-06-20
2021-02-19
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Multiplex PCR + Current strategy
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.
Multiplex PCR
Quick adaptation of antibiotic treatment according to the species identified and to the results of the resistance markers present in the multiplex PCR
Current strategy alone
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
Current strategy alone
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
Interventions
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Multiplex PCR
Quick adaptation of antibiotic treatment according to the species identified and to the results of the resistance markers present in the multiplex PCR
Current strategy alone
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 hospitalized in palliative care unit
* Persons with an estimated survival of less than one month
18 Years
ALL
No
Sponsors
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GenMark Diagnostics
INDUSTRY
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Yvan CASPAR, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Grenoble University Hospital
Grenoble, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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38RC15.091
Identifier Type: -
Identifier Source: org_study_id