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

Civil Hospices of Lyon

Status

Enrolling

Conditions

Sepsis

Treatments

Biological: blood sample - Bacteraemia group

Other: no intervention - Emergency group

Other: no intervention - Contamination group

Study type

Observational

Funder types

Other

Identifiers

NCT06219135

2023-A01260-45 (Other Identifier)

69HCL23_0542

Details and patient eligibility

About

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.

Enrollment

1,372 estimated patients

Sex

All

Ages

1+ day old

Volunteers

No Healthy Volunteers

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