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

Sepsis Clinical Trial

— IDBIORIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219135
• Other study ID #: 69HCL23_0542
• Secondary ID: 2023-A01260-45
• Status: Recruiting
• Start date: March 21, 2024
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: François VANDENESCH, Pr
• Phone: 4 72 07 11 11
• Email: francois.vandenesch[@]univ-lyon1.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1372
• Est. completion date: May 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Susceptibility
• Sepsis
• Toxemia

Intervention

Other:
• no intervention - Contamination group
there is no intervention for this group of patients

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

Locations

Country	Name	City	State
France	Femme Mère enfant Hospital	Bron
France	Femme Mère Enfant Hospital	Bron
France	Louis Pradel Hospital	Bron
France	Louis Pradel Hospital	Bron
France	Louis Pradel Hospital	Bron
France	Pierre Wertheimer Hospital	Bron
France	Croix Rousse Hospital	Lyon
France	Croix Rousse Hospital	Lyon
France	Croix Rousse Hospital	Lyon
France	Croix Rousse Hospital	Lyon
France	Croix Rousse Hospital	Lyon
France	Croix Rousse Hospital	Lyon
France	Edouard Herriot Hospital	Lyon
France	Edouard Herriot Hospital	Lyon
France	Edouard Herriot Hospital	Lyon
France	Lyon Sud Hospital	Pierre-Bénite
France	Lyon Sud Hospital	Pierre-Bénite
France	Lyon Sud Hospital	Pierre-Bénite
France	Charpennes Hospital	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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