Sepsis
Conditions
Keywords
Sepsis, bacteria, microbiology diagnosis method, identification, resistance, antibiotic susceptibility testing, virulence
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.
Interventions
OTHERno intervention - Contamination group
there is no intervention for this group of patients
BIOLOGICALblood 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
OTHERno intervention - Emergency group
there is no intervention for this group of patients
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 24 Hours to 48 Hours after inclusion | Reference technique used = Vitek MS ® (MALDI-ToF) bioMérieux. |
| 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 | 24 Hours to 48 Hours after inclusion | 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. |
Countries
France
Contacts
CONTACTFrançois VANDENESCH, Pr
STUDY_DIRECTORFrançois VANDENESCH, Pr
Hospices Civils LYON
Outcome results
None listed