ClinicalTrials.gg
CompletedNCT05741424BacteREVEALUpdated Sep 16, 2026

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

An interventional study of Innovative diagnostic technologies and Reference diagnostic technique in Bacteremia, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies in Bacteremia with a site in France — 7 open to participants now, 8 under way, none of them phase 3. Bacteremia · France.

Enrollment
11th of 15
100 · median 200
Started
2023
the only one that year
No phase
11 of 33
4 open now
Registered
23rd of 33
by date
Lead sponsor
2 of 33
Centre Hospitalier Universitaire de Nīmes

Among the 33 studies in Bacteremia with a site in France, this one is the 11th largest by enrollment of the 15 interventional ones, is the only one that started in 2023, is one of 11 with no phase, and was the 23rd registered.

By phase

33 studies; the count open now beside each. This study's row is marked.

Observational18 · 3 open
No phasethis study11 · 4 open
Phase 42 · 0 open
Phase 21 · 0 open
Phase 31 · 0 open

By the year they started

First in 1997; this study’s year is marked. 1 started in 2023.

Size and results

Median enrollment 200 across the 15 interventional studies, 200 across the 18 observational. Of the 23 that completed or were terminated, 1 (4%) have results posted.

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02

Study 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.

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.

03

Conditions studied

  • Bacteremia

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 or included by emergency procedure
  • Patient signed the consent form or included by emergency procedure

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    After innovative diagnostic technologies

    Diagnostic Test: Innovative diagnostic technologies · Diagnostic Test: Reference diagnostic technique

Interventions

  • Diagnostic testInnovative diagnostic technologies

    Samples from patients positive for Gram-negative bacteremia will be analyzed using the new BacT/Alert® VIRTUO®, BioFire® BCID2 and REVEAL® diagnostic solutions

  • Diagnostic testReference diagnostic technique

    Analysis of samples using diffusion on Mueller Hinton (MH) agar medium according to EUCAST.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours

Secondary outcomes

  1. 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

    Time frame: 28 Days

  2. 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)

    Time frame: 28 Days

  3. Patient survival

    Vital status of patients

    Time frame: 28 Days

  4. Length of stay in intensive care unit

    Number of days

    Time frame: 28 Days

  5. Prevalence rate of multiresistant bacteria between the "before" and "after" periods

    Proportion of multiresistant bacteria in each evaluation period

    Time frame: 28 Days

  6. 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

    Time frame: 28 Days

  7. cost of the device for the healthcare facility

    purchase price of the equipment, depreciation, consumables, additional human time if applicable

    Time frame: 28 Days

  8. Compare the amount per patient from the health insurance point of view.

    amount associated with the number of days spent in intensive care

    Time frame: 28 Days

07

Study locations

1 site
  • CHU de Nîmes
    Nîmes, France
08

References and documents

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 42721154 ↗
  • Oudiane 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in May 2024, 13 months.

Of 34 non-industry interventional studies with no phase under Bacteremia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 64. This study's 13 months is below that.

Counting every sponsor, half of 35 studies reached it within 34 months; a quarter within 13 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2023
First posted
Feb 23, 2023
StartActual
Mar 8, 2023
Primary completionActual
May 6, 2024
CompletionActual
Jun 16, 2024
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05741424
Collaborators
BioMérieux
Responsible party
Sponsor
First posted
Feb 23, 2023
Start date
Mar 8, 2023
Primary completion
May 6, 2024
Completion
Jun 16, 2024
Last update
Sep 16, 2026

Study contacts

Alix Pantel
principal investigator · CHU de Nimes
Claire Roger
principal investigator · CHU de Nimes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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