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

NCT03876990 | Completed

• 1 other identifier: 38RC15.091
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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).

Conditions

Bacteremia Sepsis; Fungemia

Keywords

multiplex PCR; blood culture; rapid diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Follow up is set to hospital length stay with a maximum of 30 days

Secondary Outcomes (11)

• Medical evaluation of the consequences of the innovative strategy compared to current strategy : 30-day mortality

  Hospital length stay with a maximum of 30 days

• Medical evaluation of the consequences of the innovative strategy compared to current strategy : complication rate

  Hospital length stay with a maximum of 30 days

• Medical evaluation of the consequences of the innovative strategy compared to current strategy : length of hospital stay

  Hospital length stay with a maximum of 30 days

• Medical evaluation of the consequences of the innovative strategy compared to current strategy : antibiotic treatment duration

  Hospital length stay with a maximum of 30 days

• Medical evaluation of the consequences of the innovative strategy compared to current strategy : delay of antibiotic/antifungal treatment modification at several time points

  Hospital length stay with a maximum of 30 days

Study Arms (2)

Multiplex PCR + Current strategy

EXPERIMENTAL

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.

Diagnostic Test: Multiplex PCR

Current strategy alone

ACTIVE COMPARATOR

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

Diagnostic Test: Current strategy alone

Interventions

Multiplex PCR DIAGNOSTIC_TEST

Quick adaptation of antibiotic treatment according to the species identified and to the results of the resistance markers present in the multiplex PCR

Multiplex PCR + Current strategy

Current strategy alone DIAGNOSTIC_TEST

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

Also known as: MALDI-TOFF identification

Current strategy alone

Eligibility Criteria

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

You may qualify if:

• Patient with bacteremia and/or fungemia defined by :
• / 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• GenMark Diagnostics: collaborator

Study Sites (1)

Grenoble University Hospital

Grenoble, 38043, France

Location

Related Publications (6)

• 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.

  PMID: 30487304 BACKGROUND

• 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.

  PMID: 26197846 BACKGROUND

• 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.

  PMID: 16625125 BACKGROUND

• 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.

  PMID: 27795335 BACKGROUND

• 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.

  PMID: 29284316 BACKGROUND

• 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.

  PMID: 27678085 BACKGROUND

MeSH Terms

Conditions

Fungemia

Condition Hierarchy (Ancestors)

Invasive Fungal Infections; Mycoses; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yvan CASPAR, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 15, 2019
• Study Start: June 20, 2019
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

FR (1)