Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2023-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Intensive Care Unit with Gram-negative bacteremia

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: End of study (June 2024)
Secondary outcomes:
measure: 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
timeFrame: 28 Days
measure: Concordance of the REVEAL® rapid antibiotic susceptibility testing technology with reference methods
timeFrame: 28 Days
measure: Patient survival
timeFrame: 28 Days
measure: Length of stay in intensive care unit
timeFrame: 28 Days
measure: Prevalence rate of multiresistant bacteria between the "before" and "after" periods
timeFrame: 28 Days
measure: Prevalence rate of bacteria which are highly resistant to emerging antibiotics between the "before" and "after" periods
timeFrame: 28 Days
measure: cost of the device for the healthcare facility
timeFrame: 28 Days
measure: Compare the amount per patient from the health insurance point of view.
timeFrame: 28 Days
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Alix Pantel
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Nimes
name: Claire Roger
role: PRINCIPAL_INVESTIGATOR
References: