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

March 26, 2024 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France, 69394
        • Not yet recruiting
        • Femme Mère Enfant Hospital
        • Principal Investigator:
          • Marine BUTIN, Pr
      • Bron, France, 69394
        • Not yet recruiting
        • Louis Pradel Hospital
        • Principal Investigator:
          • Gilles RIOUFOL, Pr
      • Bron, France, 69394
        • Not yet recruiting
        • Pierre Wertheimer Hospital
        • Principal Investigator:
          • Frederic DAILLER, Dr
      • Lyon, France, 69003
        • Recruiting
        • Edouard Herriot Hospital
        • Principal Investigator:
          • Anne Claire LUKASZEWICZ, Pr
      • Lyon, France, 69003
        • Not yet recruiting
        • Edouard Herriot Hospital
        • Principal Investigator:
          • Magali AUBINEAU, Dr
      • Lyon, France, 69004
        • Not yet recruiting
        • Croix Rousse Hospital
        • Principal Investigator:
          • Jean Christophe RICHARD, Pr
      • Pierre-Bénite, France, 69495
        • Not yet recruiting
        • Lyon Sud Hospital
        • Principal Investigator:
          • Franck PLAISANT, Dr
      • Villeurbanne, France, 69100
        • Not yet recruiting
        • Charpennes Hospital
        • Principal Investigator:
          • Alain SARCIRON, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will focus on adult and pediatric patients hospitalized in 19 clinical departments of the Hospices Civils de Lyon and presenting a first positive blood culture detected on the microbiology laboratory of the Institut des Agents Infectieux.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
contamination
Patients with a positive blood culture due to contamination microorganism
Other: no intervention - Contamination group
there is no intervention for this group of patients
Bacteraemia
This group includes all adults and children with a positive blood culture due to pathogen microorganism
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

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.
24 Hours to 48 Hours after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Study Director: François VANDENESCH, Pr, Hospices Civils Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_0542
  • 2023-A01260-45 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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