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

NCT ID: NCT05741424

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2024-06-16

Brief Summary

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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.

Detailed Description

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Conditions

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Bacteremia

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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After innovative diagnostic technologies

Group Type EXPERIMENTAL

Innovative diagnostic technologies

Intervention Type DIAGNOSTIC_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 technique

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Reference diagnostic technique

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioMérieux

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alix Pantel

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Claire Roger

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

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CHU de Nîmes

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 40754712 (View on PubMed)

Other Identifiers

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CIVI/2022/AP-01

Identifier Type: -

Identifier Source: org_study_id

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