NCT05741424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

March 8, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2024

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

February 14, 2023

Last Update Submit

January 12, 2026

Conditions

Bacteremia

Outcome Measures

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

    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

    28 Days

  • Concordance of the REVEAL® rapid antibiotic susceptibility testing technology with reference methods

    28 Days

  • Patient survival

    28 Days

  • Length of stay in intensive care unit

    28 Days

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

    28 Days

  • +3 more secondary outcomes

Study Arms (1)

After innovative diagnostic technologies

EXPERIMENTAL
Diagnostic Test: Innovative diagnostic technologiesDiagnostic Test: Reference diagnostic technique

Interventions

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

After innovative diagnostic technologies
Reference diagnostic techniqueDIAGNOSTIC_TEST

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

After innovative diagnostic technologies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Consent refusal
  • Patient with a polymicrobial blood culture
  • Patient with a second episode of bacteremia
  • Moribund patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, France

Location

Related Publications (1)

  • 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.

    PMID: 40754712RESULT

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alix Pantel

    CHU de Nimes

    PRINCIPAL INVESTIGATOR

  • Claire Roger

    CHU de Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 23, 2023

Study Start

March 8, 2023

Primary Completion

May 6, 2024

Study Completion

June 16, 2024

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

FR(1)