SepsisIDBIORIVNCT06219135
Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis
An observational study of Sepsis, run by Hospices Civils de Lyon at 23 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Sepsis
- What is being tested?
- blood sample - Bacteraemia group
- How many people
- 1,372 participants
- Where
- 23 sitesFrance
- Study dates
- 21 Mar 2024to 21 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients under court protection
- Patients under guardianship or curatorship
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
France23 sites, 23 recruiting
- Recruiting
Femme Mère enfant Hospital
Bron, 69394
Etienne JAVOUHAY, Pr
- Recruiting
Femme Mère Enfant Hospital
Bron, 69394
Marine BUTIN, Pr
- Not yet recruiting
Femme Mère enfant Hospital
Bron, 69394
Yves GILLET
Yves GILLET
- Recruiting
Louis Pradel Hospital
Bron, 69394
Eric BONNEFOY CUDRAZ, Pr
- Recruiting
Louis Pradel Hospital
Bron, 69394
Jean Luc FELLAHI, Pr
- Recruiting
Louis Pradel Hospital
Bron, 69394
Gilles RIOUFOL, Pr
- Recruiting
Pierre Wertheimer Hospital
Bron, 69394
Frederic DAILLER, Dr
- Recruiting
Edouard Herriot Hospital
Lyon, 69003
Anne Claire LUKASZEWICZ, Pr
- Recruiting
Edouard Herriot Hospital
Lyon, 69003
Laurent ARGAUD, Pr
- Not yet recruiting
Edouard Herriot Hospital
Lyon, 69003
Magali AUBINEAU, Dr
- Not yet recruiting
Edouard Herriot Hospital
Lyon, 69003
Karim TAZAROURTE, karim.tazarourte@chu-lyon.fr
Karim TAZAROURTE
- Recruiting
Croix Rousse Hospital
Lyon, 69004
Florence ADER, Pr
Florence ADER, Pr
- Not yet recruiting
Croix Rousse Hospital
Lyon, 69004
Pierre LANTELME, Pr
- Recruiting
Croix Rousse Hospital
Lyon, 69004
Céline GUICHON, Dr
- Recruiting
Croix Rousse Hospital
Lyon, 69004
Sylvain Gaujard, Dr
- Recruiting
Croix Rousse Hospital
Lyon, 69004
Pascal SEVE, Dr
- Recruiting
Croix Rousse Hospital
Lyon, 69004
Jean Christophe RICHARD, Pr
- Not yet recruiting
Croix Rousse Hospital
Lyon, 69004
Romain HERNU, romain.hernu@chu-lyon.fr
Romain HERNU
- Recruiting
Lyon Sud Hospital
Pierre-Bénite, 69495
Arnaud FRIGGERI, Pr
- Recruiting
Lyon Sud Hospital
Pierre-Bénite, 69495
Isabelle DURIEU, Pr
- Not yet recruiting
Lyon Sud Hospital
Pierre-Bénite, 69495
Franck PLAISANT, Dr
- Not yet recruiting
Lyon Sud Hospital
Pierre-Bénite
Marion DOUPLAT, marion.douplat@chu-lyon.fr
Marion DOUPLAT
- Recruiting
Charpennes Hospital
Villeurbanne, 69100
Alain SARCIRON, Dr
About this study
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.
Read more
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.
- Conditions
- Sepsis
- Being tested
- no intervention - Contamination group, blood sample - Bacteraemia group, no intervention - Emergency group
- Keywords
- Sepsis, bacteria, microbiology diagnosis method, identification, resistance, antibiotic susceptibility testing, virulence
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention - Contamination groupOther
there is no intervention for this group of patients
blood sample - Bacteraemia groupBiological
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 groupOther
there is no intervention for this group of patients
| Study group | Role | What they receive |
|---|---|---|
| Contamination | Patients with a positive blood culture due to contamination microorganism Receives: Other: no intervention - Contamination group | |
| Bacteraemia | This group includes all adults and children with a positive blood culture due to pathogen microorganism Receives: Biological: blood sample - Bacteraemia group | |
| Emergency | Emergency Room Patient's with a positive blood culture due to pathogen and/or contamination microorganism Receives: Other: no intervention - Emergency group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 Hours to 48 Hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start21 Mar 2024
- Primary completion21 Nov 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François VANDENESCH, Pr, Study director, Hospices Civils LYON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219135
- Sponsor's protocol ID
- 69HCL23_0542
- Other IDs
- 2023-A01260-45
- Acronym
- IDBIORIV
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT06219135
- Acronym / sponsor ID
- IDBIORIV / 69HCL23_0542
- Conditions
- Sepsis
- Keywords
- Sepsis, bacteria, microbiology diagnosis method, identification, resistance, antibiotic susceptibility testing, virulence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,372 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Contamination | – | Other: no intervention - Contamination groupPatients with a positive blood culture due to contamination microorganism |
| Bacteraemia | – | Biological: blood sample - Bacteraemia groupThis group includes all adults and children with a positive blood culture due to pathogen microorganism |
| Emergency | – | Other: no intervention - Emergency groupEmergency Room Patient's with a positive blood culture due to pathogen and/or contamination microorganism |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under court protection
- Patients under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention - Contamination groupthere is no intervention for this group of patients | Other | Contamination |
| blood sample - Bacteraemia groupfor 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 | Biological | Bacteraemia |
| no intervention - Emergency groupthere is no intervention for this group of patients | Other | Emergency |
Primary outcome
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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François VANDENESCH, Pr study director
Hospices Civils LYON
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Hospices Civils de Lyon at 23 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François VANDENESCH, Pr (4 72 07 11 11 ext. +33, francois.vandenesch@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 24 Hours to 48 Hours after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.