CompletedNot Applicable

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

France312 participantsStarted 2019-06-20

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Delay from suspicion of sepsis to optimized antibiotic/antifungal treatment

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

Trial details

NCT IDNCT03876990

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-19