BacteremiaBacteREVEALNCT05741424
Impact of BacT/Alert® VIRTUO®, BioFire® Blood Culture Identification 2-BCID2 and REVEAL® (bioMérieux) on the Optimization of Antibiotic Therapy for Gram-negative Bacteremia in the ICU
A study testing Innovative diagnostic technologies and Reference diagnostic technique in people with Bacteremia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Bacteremia is a frequent infection in intensive care units. It is associated with a high mortality rate and the rapid implementation of appropriate antibiotic therapy is strongly correlated to patient clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- Innovative diagnostic technologies and Reference diagnostic technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2023to 16 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be a member or beneficiary of a health insurance plan
- Patient admitted to the ICU with at least one positive blood culture for Gram-negative bacteremia
- For the 'after' section of the study only:
- Patient must have given their free and informed consent or included by emergency procedure
- Patient signed the consent form or included by emergency procedure
Who cannot join
- The subject is participating in this study, or is in a period of exclusion determined by a previous study
- Consent refusal
- Patient with a polymicrobial blood culture
- Patient with a second episode of bacteremia
- Moribund patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Before-and-after Study Evaluating the Impact of BacT/Alert® VIRTUO®, BioFire® Blood Culture Identification 2-BCID2 and REVEAL® (bioMérieux) on the Optimization of Antibiotic Therapy for Gram-negative Bacteremia in the ICU Patient
Bacteremia is a frequent infection in intensive care units. It is associated with a high mortality rate and the rapid implementation of appropriate antibiotic therapy is strongly correlated to patient clinical outcomes.
Innovative technologies have emerged to shorten the turnaround time of blood culture samples by obtaining susceptibility testing of the incriminated pathogen at an early stage, and therefore to rapidly adjust the antibiotic therapy of patients with Gram-negative Bacilli bacteremia.
The study investigators hypothesize that the implementation of the innovative BacT/Alert® VIRTUO®, BioFire® BCID2 and REVEAL® solutions for the analysis of blood culture samples will increase the proportion of patients with Gram-negative Bacilli bacteremia who receive appropriate and optimized antibiotic therapy 24 hours after blood culture collection.
- Conditions
- Bacteremia
- Being tested
- Innovative diagnostic technologies, Reference diagnostic technique
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative diagnostic technologiesDiagnostic test
Samples from patients positive for Gram-negative bacteremia will be analyzed using the new BacT/Alert® VIRTUO®, BioFire® BCID2 and REVEAL® diagnostic solutions
Reference diagnostic techniqueDiagnostic test
Analysis of samples using diffusion on Mueller Hinton (MH) agar medium according to EUCAST.
| Study group | Role | What they receive |
|---|---|---|
| After innovative diagnostic technologies | Experimental | Not described Receives: Diagnostic Test: Innovative diagnostic technologies; Diagnostic Test: Reference diagnostic technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients receiving optimized antibiotic therapy (adequate and narrowest spectrum antibiotic therapy) in patients with Gram-negative bacteremia 24 hours after blood culture samples
Yes/no: receiving optimized antibiotic therapy (effective and narrowest spectrum for the identified pathogen(s)) 24 hours after blood culture collection, before and after implementation of the new diagnostic solutions
Measured: 24 hours
Secondary outcomes (8)
Time to adapt antibiotic therapy (optimized) based on susceptibility testing between the two periods of the study (before and after the implementation of innovative diagnostic technologies) following the collection of blood cultures
Hours (theoretical and real) between blood culture collection and the first change in antibiotic therapy based on the innovative diagnostic technologies solutions or the conventional susceptibility test
Measured: 28 Days
Concordance of the REVEAL® rapid antibiotic susceptibility testing technology with reference methods
Categorical Agreement of antibiotics tested by REVEAL® technology compared to the reference method (agar plate susceptibility test)
Measured: 28 Days
Patient survival
Vital status of patients
Measured: 28 Days
Length of stay in intensive care unit
Number of days
Measured: 28 Days
Prevalence rate of multiresistant bacteria between the "before" and "after" periods
Proportion of multiresistant bacteria in each evaluation period
Measured: 28 Days
Prevalence rate of bacteria which are highly resistant to emerging antibiotics between the "before" and "after" periods
Proportion of bacteria which are highly resistant to emerging antibiotics in each evaluation period
Measured: 28 Days
cost of the device for the healthcare facility
purchase price of the equipment, depreciation, consumables, additional human time if applicable
Measured: 28 Days
Compare the amount per patient from the health insurance point of view.
amount associated with the number of days spent in intensive care
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start8 Mar 2023
- Primary completion6 May 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
- Investigators
- Alix Pantel, Principal investigator, CHU de NimesClaire Roger, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741424
- Sponsor's protocol ID
- CIVI/2022/AP-01
- Acronym
- BacteREVEAL
- Status last verified
- Jan 2026
- First submitted
- 14 Feb 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benyahia M, Roger C, Boutet-Dubois A, Salipante F, Oudiane L, Curtil Dit Galin M, Nsiri R, Brochon L, Lavigne JP, Pantel A. Real-life evaluation of BioFire(R) BCID2 and Vitek(R) REVEALTM for Gram-negative bloodstream infections in critical care. PLoS One. 2026 Sep 10;21(9):e0356199. doi: 10.1371/journal.pone.0356199. eCollection 2026.
PubMed 42721154Oudiane L, Benyahia M, Salipante F, Dubois A, Muller L, Lavigne JP, Pantel A, Roger C. Clinical impact of the BCID2 and rapid AST VITEK(R) REVEALTM on antibiotic optimisation in critically ill patients with Gram-negative bloodstream infections: a quasi-experimental pre/post interventional study. J Antimicrob Chemother. 2025 Oct 3;80(10):2665-2675. doi: 10.1093/jac/dkaf271.
PubMed 40754712
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Before-and-after Study Evaluating the Impact of BacT/Alert® VIRTUO®, BioFire® Blood Culture Identification 2-BCID2 and REVEAL® (bioMérieux) on the Optimization of Antibiotic Therapy for Gram-negative Bacteremia in the ICU Patient
- ClinicalTrials.gov ID
- NCT05741424
- Acronym / sponsor ID
- BacteREVEAL / CIVI/2022/AP-01
- Conditions
- Bacteremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 23 Feb 2023 (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.
Bacteremia is a frequent infection in intensive care units. It is associated with a high mortality rate and the rapid implementation of appropriate antibiotic therapy is strongly correlated to patient clinical outcomes.
Innovative technologies have emerged to shorten the turnaround time of blood culture samples by obtaining susceptibility testing of the incriminated pathogen at an early stage, and therefore to rapidly adjust the antibiotic therapy of patients with Gram-negative Bacilli bacteremia.
The study investigators hypothesize that the implementation of the innovative BacT/Alert® VIRTUO®, BioFire® BCID2 and REVEAL® solutions for the analysis of blood culture samples will increase the proportion of patients with Gram-negative Bacilli bacteremia who receive appropriate and optimized antibiotic therapy 24 hours after blood culture collection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| After innovative diagnostic technologies | Experimental | Diagnostic Test: Innovative diagnostic technologies, Diagnostic Test: Reference diagnostic technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must be a member or beneficiary of a health insurance plan
- Patient admitted to the ICU with at least one positive blood culture for Gram-negative bacteremia
- Patient must have given their free and informed consent or included by emergency procedure
- Patient signed the consent form or included by emergency procedure
Key exclusion criteria (5 listed)
- The subject is participating in this study, or is in a period of exclusion determined by a previous study
- Consent refusal
- Patient with a polymicrobial blood culture
- Patient with a second episode of bacteremia
- Moribund patient
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 |
|---|---|---|
| Innovative diagnostic technologiesSamples from patients positive for Gram-negative bacteremia will be analyzed using the new BacT/Alert® VIRTUO®, BioFire® BCID2 and REVEAL® diagnostic solutions | Diagnostic test | After innovative diagnostic technologies |
| Reference diagnostic techniqueAnalysis of samples using diffusion on Mueller Hinton (MH) agar medium according to EUCAST. | Diagnostic test | After innovative diagnostic technologies |
Primary outcome
Proportion of patients receiving optimized antibiotic therapy (adequate and narrowest spectrum antibiotic therapy) in patients with Gram-negative bacteremia 24 hours after blood culture samples
Time frame: 24 hours
Yes/no: receiving optimized antibiotic therapy (effective and narrowest spectrum for the identified pathogen(s)) 24 hours after blood culture collection, before and after implementation of the new diagnostic solutions
8 secondary outcomes
Time to adapt antibiotic therapy (optimized) based on susceptibility testing between the two periods of the study (before and after the implementation of innovative diagnostic technologies) following the collection of blood cultures
Time frame: 28 Days
Concordance of the REVEAL® rapid antibiotic susceptibility testing technology with reference methods
Time frame: 28 Days
Patient survival
Time frame: 28 Days
Length of stay in intensive care unit
Time frame: 28 Days
Prevalence rate of multiresistant bacteria between the "before" and "after" periods
Time frame: 28 Days
Prevalence rate of bacteria which are highly resistant to emerging antibiotics between the "before" and "after" periods
Time frame: 28 Days
cost of the device for the healthcare facility
Time frame: 28 Days
Compare the amount per patient from the health insurance point of view.
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Results publication: PubMed 42721154Benyahia M, Roger C, Boutet-Dubois A, Salipante F, Oudiane L, Curtil Dit Galin M, Nsiri R, Brochon L, Lavigne JP, Pantel A. Real-life evaluation of BioFire(R) BCID2 and Vitek(R) REVEALTM for Gram-negative bloodstream infections in critical care. PLoS One. 2026 Sep 10;21(9):e0356199. doi: 10.1371/journal.pone.0356199. eCollection 2026.
- Results publication: PubMed 40754712Oudiane L, Benyahia M, Salipante F, Dubois A, Muller L, Lavigne JP, Pantel A, Roger C. Clinical impact of the BCID2 and rapid AST VITEK(R) REVEALTM on antibiotic optimisation in critically ill patients with Gram-negative bloodstream infections: a quasi-experimental pre/post interventional study. J Antimicrob Chemother. 2025 Oct 3;80(10):2665-2675. doi: 10.1093/jac/dkaf271.
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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. This study is not recruiting at the moment.
Alix Pantel principal investigator
CHU de Nimes
Claire Roger principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative diagnostic technologies and Reference diagnostic technique in people with Bacteremia, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 5 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: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients receiving optimized antibiotic therapy (adequate and narrowest spectrum antibiotic therapy) in patients with Gram-negative bacteremia 24 hours after blood culture samples (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741424, which also lists 2 linked publications.
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 16 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.