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Completed

NCT Number: NCT05741424

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

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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Innovative diagnostic technologies

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

Diagnostic Test

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

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

    Time frame: 24 hours

    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

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

    Time frame: 28 Days

    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

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

    Time frame: 28 Days

    Categorical Agreement of antibiotics tested by REVEAL® technology compared to the reference method (agar plate susceptibility test)

  3. Patient survival

    Time frame: 28 Days

    Vital status of patients

  4. Length of stay in intensive care unit

    Time frame: 28 Days

    Number of days

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

    Time frame: 28 Days

    Proportion of multiresistant bacteria in each evaluation period

  6. Prevalence rate of bacteria which are highly resistant to emerging antibiotics between the "before" and "after" periods

    Time frame: 28 Days

    Proportion of bacteria which are highly resistant to emerging antibiotics in each evaluation period

  7. cost of the device for the healthcare facility

    Time frame: 28 Days

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

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

    Time frame: 28 Days

    amount associated with the number of days spent in intensive care

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • BioMérieux

Registry information

Official study title

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

Acronym: BacteREVEAL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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