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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01260-45 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention - Contamination group | Other | there is no intervention for this group of patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study will focus on adult and pediatric patients hospitalized in 23 clinical departments of the Hospices Civils de Lyon and presenting a first positive blood culture detected on the microbiology laboratory of the Institut des Agents Infectieux.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François VANDENESCH, Pr | Contact | 4 72 07 11 11 | +33 | francois.vandenesch@univ-lyon1.fr |
| Name | Affiliation | Role |
|---|---|---|
| François VANDENESCH, Pr | Hospices Civils LYON | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Femme Mère enfant Hospital | Recruiting | Bron | 69394 | France |
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For each participant, a strain of the detected pathogen will be stored at the Institut des Agents Infectieux of the Centre de Biologie and Pathologie Nord of the Hôpital de la Croix Rousse 69004 Lyon.
In option, for adult patients with Bacteraemia (bacteraemia group only), a blood sample will be drawn at visit H24-48 and J30. Analysis will be done at Laboratoire Commun de Recherche Hospices Civils de Lyon-bioMérieux, 69310 Pierre Bénite
| blood sample - Bacteraemia group | 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 |
|
| no intervention - Emergency group | Other | there is no intervention for this group of patients |
|
| Femme Mère Enfant Hospital | Recruiting | Bron | 69394 | France |
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| Femme Mère enfant Hospital | Not yet recruiting | Bron | 69394 | France |
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| Louis Pradel Hospital | Recruiting | Bron | 69394 | France |
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| Louis Pradel Hospital | Recruiting | Bron | 69394 | France |
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| Louis Pradel Hospital | Recruiting | Bron | 69394 | France |
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| Pierre Wertheimer Hospital | Recruiting | Bron | 69394 | France |
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| Edouard Herriot Hospital | Recruiting | Lyon | 69003 | France |
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| Edouard Herriot Hospital | Recruiting | Lyon | 69003 | France |
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| Edouard Herriot Hospital | Not yet recruiting | Lyon | 69003 | France |
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| Edouard Herriot Hospital | Not yet recruiting | Lyon | 69003 | France |
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| Croix Rousse Hospital | Recruiting | Lyon | 69004 | France |
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| Croix Rousse Hospital | Not yet recruiting | Lyon | 69004 | France |
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| Croix Rousse Hospital | Recruiting | Lyon | 69004 | France |
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| Croix Rousse Hospital | Recruiting | Lyon | 69004 | France |
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| Croix Rousse Hospital | Recruiting | Lyon | 69004 | France |
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| Croix Rousse Hospital | Recruiting | Lyon | 69004 | France |
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| Croix Rousse Hospital | Not yet recruiting | Lyon | 69004 | France |
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| Lyon Sud Hospital | Recruiting | Pierre-Bénite | 69495 | France |
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| Lyon Sud Hospital | Recruiting | Pierre-Bénite | 69495 | France |
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| Lyon Sud Hospital | Not yet recruiting | Pierre-Bénite | 69495 | France |
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| Lyon Sud Hospital | Not yet recruiting | Pierre-Bénite | France |
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| Charpennes Hospital | Recruiting | Villeurbanne | 69100 | France |
|
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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