Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis
IDBIORIV
2 other identifiers
observational
1,372
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2023
CompletedFirst Posted
Study publicly available on registry
January 23, 2024
CompletedStudy Start
First participant enrolled
March 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 21, 2026
June 10, 2026
June 1, 2026
2.7 years
December 6, 2023
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
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
Study Arms (3)
Contamination
Patients with a positive blood culture due to contamination microorganism
Bacteraemia
This group includes all adults and children with a positive blood culture due to pathogen microorganism
Emergency
Emergency Room Patient's with a positive blood culture due to pathogen and/or contamination microorganism
Interventions
there is no intervention for this group of patients
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
Eligibility Criteria
This study will focus on adult and pediatric patients hospitalized in 23 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.
You may qualify if:
- 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
You may not qualify if:
- Patients under court protection
- Patients under guardianship or curatorship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Femme Mère enfant Hospital
Bron, 69394, France
Femme Mère Enfant Hospital
Bron, 69394, France
Femme Mère enfant Hospital
Bron, 69394, France
Louis Pradel Hospital
Bron, 69394, France
Louis Pradel Hospital
Bron, 69394, France
Louis Pradel Hospital
Bron, 69394, France
Pierre Wertheimer Hospital
Bron, 69394, France
Edouard Herriot Hospital
Lyon, 69003, France
Edouard Herriot Hospital
Lyon, 69003, France
Edouard Herriot Hospital
Lyon, 69003, France
Edouard Herriot Hospital
Lyon, 69003, France
Croix Rousse Hospital
Lyon, 69004, France
Croix Rousse Hospital
Lyon, 69004, France
Croix Rousse Hospital
Lyon, 69004, France
Croix Rousse Hospital
Lyon, 69004, France
Croix Rousse Hospital
Lyon, 69004, France
Croix Rousse Hospital
Lyon, 69004, France
Croix Rousse Hospital
Lyon, 69004, France
Lyon Sud Hospital
Pierre-Bénite, 69495, France
Lyon Sud Hospital
Pierre-Bénite, 69495, France
Lyon Sud Hospital
Pierre-Bénite, 69495, France
Lyon Sud Hospital
Pierre-Bénite, France
Charpennes Hospital
Villeurbanne, 69100, France
Biospecimen
For each participant, a strain of the detected pathogen will be stored at the Institut des Agents Infectieux of the Centre de Biologie and Pathologie Nord of the Hôpital de la Croix Rousse 69004 Lyon. In option, for adult patients with Bacteraemia (bacteraemia group only), a blood sample will be drawn at visit H24-48 and J30. Analysis will be done at Laboratoire Commun de Recherche Hospices Civils de Lyon-bioMérieux, 69310 Pierre Bénite
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
François VANDENESCH, Pr
Hospices Civils LYON
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2023
First Posted
January 23, 2024
Study Start
March 21, 2024
Primary Completion (Estimated)
November 21, 2026
Study Completion (Estimated)
November 21, 2026
Last Updated
June 10, 2026
Record last verified: 2026-06