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

Study Overview
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Brief Summary
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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.

Official Title
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Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia: a Prospective, Non-interventional, Multi-centric, Clinical Performance Study

Conditions
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Bacteremia Sepsis

Intervention / Treatment
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* Diagnostic Test: Resistell Phenotech


Participation Criteria
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Eligibility Criteria
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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

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Resistell Phenotech|Resistell Phenotech IVD device used to assess susceptibility of Gram negative bacteria to antibiotics.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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 | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic, Susceptibility, AST, E.coli, K. pneumoniae, Phenotech