Clinical trial NCT06219135: Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis
Official title: Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Keywords: Sepsis
bacteria
microbiology diagnosis method
identification
resistance
antibiotic susceptibility testing
virulence
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 1372
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 24 Hours to 48 Hours after inclusion
measure: 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
timeFrame: 24 Hours to 48 Hours after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Femme Mère enfant Hospital
city: Bron
country: France
facility: Femme Mère Enfant Hospital
city: Bron
country: France
facility: Femme Mère enfant Hospital
city: Bron
country: France
facility: Louis Pradel Hospital
city: Bron
country: France
facility: Louis Pradel Hospital
city: Bron
country: France
facility: Louis Pradel Hospital
city: Bron
country: France
facility: Pierre Wertheimer Hospital
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Pierre-Bénite
country: France
facility: Lyon Sud Hospital
city: Pierre-Bénite
country: France
facility: Lyon Sud Hospital
city: Pierre-Bénite
country: France
facility: Lyon Sud Hospital
city: Pierre-Bénite
country: France
facility: Lyon Sud Hospital
city: Villeurbanne
country: France
facility: Charpennes Hospital
Study officials:
affiliation: Hospices Civils LYON
name: François VANDENESCH, Pr
role: STUDY_DIRECTOR
References: