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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2025 by Hospices Civils de Lyon
Sponsor
Hospices Civils de Lyon
Information Provided by (Responsible Party)
Hospices Civils de Lyon
Clinicaltrials.gov Identifier
NCT06219135
Other Study ID Numbers:
69HCL23_0542
First Submitted
December 5, 2023
First Posted
January 22, 2024
Last Update Posted
March 9, 2025
Last Verified
February 2025

ClinicalTrials.gov processed this data on March 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Sepsis
Other: no intervention - Contamination groupBiological: blood sample - Bacteraemia groupOther: no intervention - Emergency group

Study Design

Study TypeObservational
Actual Enrollment1372 participants
Official TitleEvaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis
Study Start DateMarch 20, 2024
Actual Primary Completion DateDecember 31, 2025
Actual Study Completion DateApril 30, 2026

Groups and Cohorts

Group/CohortIntervention/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
Emergency
Emergency Room Patient's with a positive blood culture due to pathogen and/or contamination microorganism
Other: no intervention - Emergency group
there is no intervention for this group of patients

Outcome Measures

Primary Outcome Measures
  1. 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.
  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 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.

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsHospices Civils de Lyon
Locations
Femme Mère enfant Hospital | Bron , France, 69394Femme Mère Enfant Hospital | Bron , France, 69394Femme Mère enfant Hospital | Bron , France, 69394Louis Pradel Hospital | Bron , France, 69394Louis Pradel Hospital | Bron , France, 69394Louis Pradel Hospital | Bron , France, 69394Pierre Wertheimer Hospital | Bron , France, 69394Edouard Herriot Hospital | Lyon , France, 69003Edouard Herriot Hospital | Lyon , France, 69003Edouard Herriot Hospital | Lyon , France, 69003Edouard Herriot Hospital | Lyon , France, 69003Croix Rousse Hospital | Lyon , France, 69004Croix Rousse Hospital | Lyon , France, 69004Croix Rousse Hospital | Lyon , France, 69004Croix Rousse Hospital | Lyon , France, 69004Croix Rousse Hospital | Lyon , France, 69004Croix Rousse Hospital | Lyon , France, 69004Croix Rousse Hospital | Lyon , France, 69004Lyon Sud Hospital | Pierre-Bénite , France, 69495Lyon Sud Hospital | Pierre-Bénite , France, 69495Lyon Sud Hospital | Pierre-Bénite , France, 69495Lyon Sud Hospital | Pierre-Bénite , France, Charpennes Hospital | Villeurbanne , France, 69100
Investigators
Study Director: François VANDENESCH, Pr, Hospices Civils LYON