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

Study Overview
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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.

Official Title
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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

Conditions
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Bacteremia

Intervention / Treatment
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* Diagnostic Test: Innovative diagnostic technologies
* Diagnostic Test: Reference diagnostic technique


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before innovative diagnostic technologies<br> | Diagnostic Test: Reference diagnostic technique<br>* Analysis of samples using diffusion on Mueller Hinton (MH) agar medium according to EUCAST.<br>|
| After innovative diagnostic technologies<br> | Diagnostic Test: Innovative diagnostic technologies<br>* Samples from patients positive for Gram-negative bacteremia will be analyzed using the new BacT/Alert® VIRTUO®, BioFire® BCID2 and REVEAL® diagnostic solutions<br>|

What is the study measuring?
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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 | End of study (June 2024) | 

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 |