Status:
COMPLETED
Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia and Fungemia.
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
GenMark Diagnostics
Conditions:
Bacteremia Sepsis
Fungemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 bacte...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2021
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT03876990
Start Date
June 20 2019
End Date
February 19 2021
Last Update
November 3 2021
Active Locations (1)
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1
Grenoble University Hospital
Grenoble, France, 38043