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 (BacteREVEAL)

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.

Study Overview

• Status: Completed
• Conditions: Bacteremia
• Intervention / Treatment: Diagnostic test: Reference diagnostic technique; Diagnostic test: Innovative diagnostic technologies

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients admitted to Intensive Care Unit with Gram-negative bacteremia

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: After innovative diagnostic technologies	Diagnostic test: Reference diagnostic technique; Analysis of samples using diffusion on Mueller Hinton (MH) agar medium according to EUCAST.; Diagnostic test: Innovative 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	28 Days
Patient survival	Vital status of patients	28 Days
Length of stay in intensive care unit	Number of days	28 Days
Prevalence rate of multiresistant bacteria between the "before" and "after" periods	Proportion of multiresistant bacteria in each evaluation period	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	28 Days
cost of the device for the healthcare facility	purchase price of the equipment, depreciation, consumables, additional human time if applicable	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	28 Days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: BioMérieux
• Investigators: Principal Investigator: Alix Pantel, CHU de Nîmes; Principal Investigator: Claire Roger, CHU de Nîmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): May 6, 2024
• Study Completion (Actual): June 16, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Pathological Conditions, Signs and Symptoms; Bacteremia
• Other Study ID Numbers: CIVI/2022/AP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No