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Completed

NCT Number: NCT03876990

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Other names: MALDI-TOFF identification

Primary outcomes

  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 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • GenMark Diagnostics

Registry information

Official study 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.

Acronym: HEMOFAST

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2019
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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