Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis - Trial NCT06219135
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Study Focus
Sponsor & Location
Hospices Civils de Lyon
Timeline & Enrollment
N/A
Mar 21, 2024
May 01, 2026
Primary Outcome
The IDBIORIV method will be compared with the current routine methods present in the Hospices Civils de Lyon. The sensitivity and specificity of the IDBIORIV method will be evaluated using the Identification (ID) results of a positive blood culture for a,The IDBIORIV method will be compared with the current routine methods present in the Hospices Civils de Lyon. The sensitivity and specificity of the IDBIORIV method will be evaluated using AST results. Reference technique = Vitek 2® bioMérieux
Summary
Sepsis is a disruption of homeostasis in the human body in response to bloodstream infection
 and is associated with a high risk of mortality.
 
 Worldwide, sepsis is affecting approximately 30 million people and resulting in six million
 deaths.
 
 Blood culture is a specific blood sample used to identifying microbial agent (bacterium or
 yeast) and determine the sensitivity of these microorganisms to antibiotics and antifungals.
 
 Any delay in identifying the microorganism and/or determining the AST (antibiotic
 susceptibility testing) has a direct impact on the administration of appropriate antibiotic
 treatment and, consequently, on mortality of the patient. The faster the diagnosis, the
 faster the antibiotic treatment will be adapted, the higher the survival rate/probability of
 patients, and the lower the ecological impact.
 
 In routine, clinical microbiology laboratories currently use 2 automatized techniques:
 MALDI-TOF MS® for microorganisms identification and VITEK2® method for AST determination.
 
 Based on a proteomic approach, the IDBIORIV method is a rapid method (90 minutes) in
 comparison of current methods (24/48 hours) able to identifying a large panel of 113
 pathogens and determine the antibiotic resistance profile of 49 species for 4 classes of
 antibiotics (Beta-lactams, Aminosides, Glycopeptides, Colistin).
 
 The main objective of this study is to evaluate the performance of the IDBIORIV method in
 pathogen identification and antibiotic susceptibility testing in comparison with current
 methods of analysis of positive blood cultures used at the microbiology laboratory of the
 Hospices Civils de Lyon, in a real clinical situation, over a 2-year period.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06219135
Non-Device Trial