Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis

Overview

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.

Interventions

• Other no intervention - Contamination group
  there is no intervention for this group of patients
• Biological blood sample - Bacteraemia group
  for adult patients, in optional, blood sample will be taken. 27,5 ml of blood at H24-48 after inclusion and 5 ml of blood at day 30
• Other no intervention - Emergency group
  there is no intervention for this group of patients

Primary outcome measures

• 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 [Time frame: 24 Hours to 48 Hours after inclusion]
• 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 [Time frame: 24 Hours to 48 Hours after inclusion]

Eligibility criteria

Inclusion criteria

• Adult or child patient
• Hospitalized in one of the departments registered with Hospices Civils de Lyon
• Showing signs of infection
• Confirmed by a 1st positive blood culture
• Patient or close relative (trustworthy person or family member) or holder of parental authority who has given his or her non-objection after receiving the information note

Exclusion criteria

• Patients under court protection
• Patients under guardianship or curatorship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 23 centers

• Femme Mère enfant Hospital — Bron
• Femme Mère Enfant Hospital — Bron
• Femme Mère enfant Hospital — Bron
• Louis Pradel Hospital — Bron
• Louis Pradel Hospital — Bron
• Louis Pradel Hospital — Bron
• Pierre Wertheimer Hospital — Bron
• Edouard Herriot Hospital — Lyon
• … and 15 more centers

Identifiers

NCT: NCT06219135 · 69HCL23_0542 · 2023-A01260-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗