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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-21

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Contamination

Patients with a positive blood culture due to contamination microorganism

no intervention - Contamination group

Intervention Type OTHER

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

blood sample - Bacteraemia group

Intervention Type BIOLOGICAL

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

no intervention - Emergency group

Intervention Type OTHER

there is no intervention for this group of patients

Interventions

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no intervention - Contamination group

there is no intervention for this group of patients

Intervention Type OTHER

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

Intervention Type BIOLOGICAL

no intervention - Emergency group

there is no intervention for this group of patients

Intervention Type OTHER

Eligibility Criteria

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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