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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05741424
Acronym
BacteREVEAL
Enrollment
100
Registered
2023-02-23
Start date
2023-03-08
Completion date
2024-06-16
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia

Brief 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.

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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER
BioMérieux
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 informed consent or included by emergency procedure * Patient signed the consent form or included by emergency procedure

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients receiving optimized antibiotic therapy (adequate and narrowest spectrum antibiotic therapy) in patients with Gram-negative bacteremia 24 hours after blood culture samples24 hoursYes/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

Secondary

MeasureTime frameDescription
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 cultures28 DaysHours (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
Concordance of the REVEAL® rapid antibiotic susceptibility testing technology with reference methods28 DaysCategorical Agreement of antibiotics tested by REVEAL® technology compared to the reference method (agar plate susceptibility test)
Patient survival28 DaysVital status of patients
Length of stay in intensive care unit28 DaysNumber of days
Prevalence rate of multiresistant bacteria between the "before" and "after" periods28 DaysProportion of multiresistant bacteria in each evaluation period
Prevalence rate of bacteria which are highly resistant to emerging antibiotics between the "before" and "after" periods28 DaysProportion of bacteria which are highly resistant to emerging antibiotics in each evaluation period
cost of the device for the healthcare facility28 Dayspurchase price of the equipment, depreciation, consumables, additional human time if applicable
Compare the amount per patient from the health insurance point of view.28 Daysamount associated with the number of days spent in intensive care

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAlix Pantel

CHU de Nimes

PRINCIPAL_INVESTIGATORClaire Roger

CHU de Nimes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026