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 Clinical Trial

— BacteREVEAL  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741424
• Other study ID #: CIVI/2022/AP-01
• Status: Recruiting
• Start date: March 8, 2023
• Est. completion date: July 2024

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Alix Pantel
• Phone: 04.66.68.32.02
• Email: alix.pantel[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia

Intervention

Diagnostic Test:
• 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
• Reference diagnostic technique
Analysis of samples using diffusion on Mueller Hinton (MH) agar medium according to EUCAST.

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	BioMérieux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient survival	Vital status of patients	28 Days
Secondary	Length of stay in intensive care unit	Number of days	28 Days
Secondary	Prevalence rate of multiresistant bacteria between the "before" and "after" periods	Proportion of multiresistant bacteria in each evaluation period	28 Days
Secondary	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