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Trial record 92 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

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

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ClinicalTrials.gov Identifier: NCT03876990
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
GenMark Diagnostics
Information provided by (Responsible Party):
University Hospital, Grenoble

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).

Condition or disease Intervention/treatment Phase
Bacteremia Sepsis Fungemia Diagnostic Test: Multiplex PCR Diagnostic Test: Current strategy alone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Diagnostic Test: 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

Active Comparator: 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
Diagnostic Test: 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 Name: MALDI-TOFF identification




Primary Outcome Measures :
  1. Delay from suspicion of sepsis to optimized antibiotic/antifungal treatment [ Time Frame: Follow up is set to hospital length stay with a maximum of 30 days ]
    Delay between first sampling of blood cultures for sepsis and optimized antibiotic/antifungal treatment. Treatment will be considered opimized 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 :
  1. Medical evaluation of the consequences of the innovative strategy compared to current strategy : 30-day mortality [ Time Frame: Hospital length stay with a maximum of 30 days ]
    The following clinical consequences will be measured and compared in each arm : 30-day mortality

  2. Medical evaluation of the consequences of the innovative strategy compared to current strategy : complication rate [ Time Frame: Hospital length stay with a maximum of 30 days ]
    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)

  3. Medical evaluation of the consequences of the innovative strategy compared to current strategy : length of hospital stay [ Time Frame: Hospital length stay with a maximum of 30 days ]
    The following clinical consequences will be measured and compared in each arm : length of hospital stay

  4. Medical evaluation of the consequences of the innovative strategy compared to current strategy : antibiotic treatment duration [ Time Frame: Hospital length stay with a maximum of 30 days ]
    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)

  5. Medical evaluation of the consequences of the innovative strategy compared to current strategy : delay of antibiotic/antifungal treatment modification at several time points [ Time Frame: Hospital length stay with a maximum of 30 days ]
    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).

  6. Medical evaluation of the consequences of the innovative strategy compared to current strategy : rate of antibiotic/antifungal treatment modification at several time points [ Time Frame: Hospital length stay with a maximum of 30 days ]
    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).

  7. Economic evaluation of the hospitalization costs of the innovative strategy compared to current strategy [ Time Frame: Hospital length stay with a maximum of 30 days ]
    Hospitalization costs will be measured

  8. Economic evaluation of the treatments costs of the innovative strategy compared to current strategy [ Time Frame: Hospital length stay with a maximum of 30 days ]
    Anti-infectious treatment costs will be measured

  9. Economic evaluation of the costs of the innovative compared to current strategy [ Time Frame: Hospital length stay with a maximum of 30 days ]
    Costs of the innovative assay (reagents and device) will be measured

  10. Economic evaluation of the medical imaging costs of the innovative strategy compared to current strategy [ Time Frame: Hospital length stay with a maximum of 30 days ]
    Medical imaging costs will be measured

  11. Economic impact of the introduction of the innovative strategy for Grenoble University Hospital [ Time Frame: Extrapolation of the costs for a one year period ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 mentionned 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876990


Contacts
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Contact: Sandra DAVID-TCHOUDA, MD +33476767186 SDavidTchouda@chugrenoble.fr
Contact: Sandrine MASSICOT, Master +33476768860 smassicot@chu-grenoble.fr

Locations
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France
Grenoble University Hospital Recruiting
Grenoble, France, 38043
Contact: Patricia PAVESE, MD    +33476769564    ppavese@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
GenMark Diagnostics
Investigators
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Principal Investigator: Yvan CASPAR, MD University Hospital, Grenoble

Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03876990     History of Changes
Other Study ID Numbers: 38RC15.091
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: September 2019

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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
Keywords provided by University Hospital, Grenoble:
multiplex PCR
blood culture
rapid diagnosis
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Bacteremia
Fungemia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Invasive Fungal Infections
Mycoses