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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Fungemia; Bacteremia Sepsis

Treatments: Diagnostic Test: Current strategy alone; Diagnostic Test: Multiplex PCR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03876990

38RC15.091

Details and patient eligibility

About

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).

Full 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.

Enrollment: 312 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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312 participants in 2 patient groups

Multiplex PCR + Current strategy

Experimental group

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.

Treatment:

Diagnostic Test: Multiplex PCR

Current strategy alone

Active Comparator group

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

Treatment:

Diagnostic Test: Current strategy alone