Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia

Resistell AG246 enrolled

Overview

The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K. pneumoniae) to clinically relevant antibiotics. The study is designed as a prospective, non-interventional, multi-center, single-arm study. The blood culture samples from bacteremia patients that are positive for E. coli or K. pneumoniae will be tested with the Resistell Phenotech device after strain identification by MALDI-TOF. The results of the Resistell AST will be compared with the results from the disk diffusion tests (all sites use the Kirby-Bauer disk diffusion test), and site dependent tests (VITEK® 2, BD Phoenix™, MicroScan WalkAway system, and/or EUCAST RAST), which are currently the standard AST methods in the microbiology laboratories at the participating sites.

Study Type

OBSERVATIONAL

Enrollment

246

Conditions

Bacteremia Sepsis

Interventions

Resistell PhenotechDIAGNOSTIC_TEST

Resistell Phenotech IVD device used to assess susceptibility of Gram negative bacteria to antibiotics.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have signed a General Consent form approving use of their residual blood samples for research purposes (applicable at CHUV only) * Patients who have signed a consent allowing the use of their residual sample (Restprobenerklärung) (applicable at MUI, only) * Patients over the age of 18 years (\>18) * Patients with bacteremia considered to be due to E. coli or K. pneumoniae * Patients whose positive blood cultures were not older than 24 hours at the time of AST start Exclusion Criteria: * Patients with documented refusal of the use of biological material for research purposes (applicable at CHUV, only) * Patients with polymicrobial bacteremia

Locations (3)

Medizinische Universität Innsbruck (MUI), Institut für Hygiene und Medizinische Mikrobiologie

Innsbruck, Innsbruck, Austria

Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)

Madrid, Madrid, Spain

Centre hospitalier universitaire vaudois (CHUV), Institut de Microbiologie

Lausanne, Lausanne, Switzerland

Outcomes

Primary Outcomes

Sensitivity of the Resistell Phenotech vs Kirby-Bauer

To assess the sensitivity of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to the gold standard Kirby-Bauer disk diffusion test.

Time frame: 18 months

Secondary Outcomes

Specificity and accuracy of the Resistell Phenotech vs Kirby-Bauer

To assess the specificity and accuracy of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to the gold standard Kirby-Bauer disk diffusion test.

Time frame: 18 months

Sensitivity, specificity, and accuracy of the Resistell Phenotech vs other comparators

To assess the sensitivity, specificity, and accuracy of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to other routine diagnostic AST tests run at each site

Time frame: 18 months

Time to result of Resistell Phenotech vs Kirby-Bauer and other comparators

To assess the difference between time to result (TTR) of Resistell Phenotech and the TTR of the Kirby-Bauer and the other routine diagnostic AST methods run at each site.

Time frame: 18 months

Category agreement and discrepancies

To assess category agreement (CA), very major discrepancy (VMD), major discrepancy (MD) of the results obtained with Resistell Phenotech compared to the Kirby-Bauer and the other routine diagnostic AST test results at each site

Time frame: 18 months