MedTrace Logo

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

NCT03876990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2021-11-03

No results posted yet for this study

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).

Conditions

  • Bacteremia Sepsis
  • Fungemia

Interventions

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

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

Sponsors & Collaborators

  • GenMark Diagnostics

    collaborator INDUSTRY

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Yvan CASPAR, MD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2021-02-19
Completion
2021-02-19

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876990 on ClinicalTrials.gov