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

Last updated: March 6, 2025
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Treatment

no intervention - Contamination group

blood sample - Bacteraemia group

no intervention - Emergency group

Clinical Study ID

NCT06219135
69HCL23_0542
2023-A01260-45
  • Ages > 1
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofparental authority who has given his or her non-objection after receiving theinformation note

Exclusion

Exclusion Criteria:

  • Patients under court protection

  • Patients under guardianship or curatorship

Study Design

Total Participants: 1372
Treatment Group(s): 3
Primary Treatment: no intervention - Contamination group
Phase:
Study Start date:
March 21, 2024
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Femme Mère Enfant Hospital

    Bron, 69394
    France

    Active - Recruiting

  • Femme Mère enfant Hospital

    Bron, 69394
    France

    Site Not Available

  • Louis Pradel Hospital

    Bron, 69394
    France

    Active - Recruiting

  • Pierre Wertheimer Hospital

    Bron, 69394
    France

    Active - Recruiting

  • Croix Rousse Hospital

    Lyon, 69004
    France

    Active - Recruiting

  • Edouard Herriot Hospital

    Lyon, 69003
    France

    Active - Recruiting

  • Lyon Sud Hospital

    Pierre-Bénite, 69495
    France

    Active - Recruiting

  • Charpennes Hospital

    Villeurbanne, 69100
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.