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

Recruiting

• Conditions: Sepsis
• Interventions: Biological: blood sample - Bacteraemia group; Other: no intervention - Contamination group; Other: no intervention - Emergency group

• Registration Number: NCT06219135
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-23
• Study Start: 2024-03-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-01
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1372

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bacteraemia	blood sample - Bacteraemia group	This group includes all adults and children with a positive blood culture due to pathogen microorganism
contamination	no intervention - Contamination group	Patients with a positive blood culture due to contamination microorganism
Contamination	no intervention - Contamination group	Patients with a positive blood culture due to contamination microorganism
Bacteraemia	blood sample - Bacteraemia group	This group includes all adults and children with a positive blood culture due to pathogen microorganism
Emergency	no intervention - Emergency group	Emergency Room Patient's with a positive blood culture due to pathogen and/or contamination microorganism

Primary Outcome Measures

Name	Time	Method
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	24 Hours to 48 Hours after inclusion	The performance of the IDBIORIV method for in vitro diagnosis of antibiotic-resistant/susceptible status will be evaluated for each "species-antibiotic" pair and "species-antibiotic group" of interest.; Sensitivity will be calculated as the proportion of pairs diagnosed as resistant using the IDBIORIV method among pairs diagnosed as resistant using AST.; Specificity will be calculated as the proportion of pairs diagnosed as sensitive with the IDBIORIV method among pairs diagnosed as sensitive with AST.
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	24 Hours to 48 Hours after inclusion	Reference technique used = Vitek MS ® (MALDI-ToF) bioMérieux.

Trial Locations

Locations (8)

Pierre Wertheimer Hospital; 🇫🇷 Bron, France

Femme Mère enfant Hospital; 🇫🇷 Bron, France

Femme Mère Enfant Hospital; 🇫🇷 Bron, France

Louis Pradel Hospital; 🇫🇷 Bron, France

Edouard Herriot Hospital; 🇫🇷 Lyon, France

Croix Rousse Hospital; 🇫🇷 Lyon, France

Lyon Sud Hospital; 🇫🇷 Pierre-Bénite, France

Charpennes Hospital; 🇫🇷 Villeurbanne, France