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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Femme Mère enfant Hospital
RECRUITING
Bron
Femme Mère enfant Hospital
NOT_YET_RECRUITING
Bron
Femme Mère Enfant Hospital
RECRUITING
Bron
Louis Pradel Hospital
RECRUITING
Bron
Pierre Wertheimer Hospital
RECRUITING
Bron
Croix Rousse Hospital
NOT_YET_RECRUITING
Lyon
Croix Rousse Hospital
NOT_YET_RECRUITING
Lyon
Croix Rousse Hospital
RECRUITING
Lyon
Croix Rousse Hospital
RECRUITING
Lyon
Edouard Herriot Hospital
NOT_YET_RECRUITING
Lyon
Edouard Herriot Hospital
RECRUITING
Lyon
Edouard Herriot Hospital
NOT_YET_RECRUITING
Lyon
Lyon Sud Hospital
RECRUITING
Pierre-bénite
Lyon Sud Hospital
NOT_YET_RECRUITING
Pierre-bénite
Lyon Sud Hospital
NOT_YET_RECRUITING
Pierre-bénite
Charpennes Hospital
RECRUITING
Villeurbanne
Contact Information
Primary
François VANDENESCH, Pr
francois.vandenesch@univ-lyon1.fr
4 72 07 11 11
Time Frame
Start Date: 2024-03-21
Estimated Completion Date: 2026-05
Participants
Target number of participants: 1372
Treatments
Contamination
Patients with a positive blood culture due to contamination microorganism
Bacteraemia
This group includes all adults and children with a positive blood culture due to pathogen microorganism
Emergency
Emergency Room Patient's with a positive blood culture due to pathogen and/or contamination microorganism
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov