NCT06219135: IDBIORIV

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

Recruiting now Last updated 6 March 2025

What this trial tests

trial testing no intervention - Contamination group in Sepsis in 1,372 participants. Currently enrolling.

Timeline

21 March 2024

Primary endpoint
1 January 2026

1 May 2026

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,372
Start date	21 March 2024
Primary completion	1 January 2026
Estimated completion	1 May 2026
Sites	23 locations across France

Drugs / interventions tested

• no intervention - Contamination group
• blood sample - Bacteraemia group — full drug profile →
• no intervention - Emergency group

Conditions studied

• Sepsis — all drugs for Sepsis →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

1 Day and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  Reference technique used = Vitek MS ® (MALDI-ToF) bioMérieux.
• 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
  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 propo

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.