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

Recruiting

• Conditions: Bacteremia
• Interventions: Diagnostic Test: Reference diagnostic technique; Diagnostic Test: Innovative diagnostic technologies

• Registration Number: NCT05741424
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-03-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Before innovative diagnostic technologies	Reference diagnostic technique	-
After innovative diagnostic technologies	Innovative diagnostic technologies	-

Primary Outcome Measures

Name	Time	Method
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	End of study (June 2024)	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 Outcome Measures

Name	Time	Method
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	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
Concordance of the REVEAL® rapid antibiotic susceptibility testing technology with reference methods	28 Days	Categorical Agreement of antibiotics tested by REVEAL® technology compared to the reference method (agar plate susceptibility test)
Patient survival	28 Days	Vital status of patients
Length of stay in intensive care unit	28 Days	Number of days
Prevalence rate of multiresistant bacteria between the "before" and "after" periods	28 Days	Proportion of multiresistant bacteria in each evaluation period
Prevalence rate of bacteria which are highly resistant to emerging antibiotics between the "before" and "after" periods	28 Days	Proportion of bacteria which are highly resistant to emerging antibiotics in each evaluation period
cost of the device for the healthcare facility	28 Days	purchase price of the equipment, depreciation, consumables, additional human time if applicable
Compare the amount per patient from the health insurance point of view.	28 Days	amount associated with the number of days spent in intensive care

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France