Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis

Study Overview
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Brief Summary
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Blood culture samples from bacteremia patients positive for Gram-negative bacteria will be tested for antibacterial susceptibility using Resistell Phenotech device. The results will be compared with current AST gold standard tests to calculate sensitivity, specificity, and accuracy of Resistell Phenotech device.

Detailed Description
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NANO-RAST: Nano-motion based Resistell AST to determine the antibiotic susceptibility of bacteria causing bacteremia and sepsis. Study population: patients admitted at the study site with bacteremia considered to be due to a pathogenic strain (E. coli or K. pneumoniae). Study design: prospective, observational, single arm study.

Official Title
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NANO-RAST: Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis

Conditions
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Bacteremia Sepsis

Intervention / Treatment
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* Diagnostic Test: Resistell AST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients meeting all the following criteria can be recruited in the study: patients over the age of 18 years who sign, or their relatives / legal representatives sign the informed consent form; patients with bacteremia considered to be due to a pathogenic strain; patients hospitalized at CHUV at the time of blood culture inoculation; patients whose positive blood cultures were not older than 24 hours at the time of AST start. Exclusion Criteria The patients meeting any of the following criteria will be excluded from the study: patient is diagnosed with polymicrobial bacteremia; samples can be excluded from the study during the processing of samples in case of technical errors e.g. failure with attachment of cells, technical problem with the device or sensor, operator's error, etc. Note: in the event that the capacity of the Resistell instruments is reached for the day, no more ICFs will be obtained for the day.

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 AST|The Resistell AST is intended for rapid antibiotic susceptibility testing of most common clinically relevant Gram-negative bacteria causing bloodstream infections (BSI) (bacteremia). In the scope of this study, the Resistell Phenotech device will be used to test the susceptibility of Gram-negative bacteria, in particular Escherichia coli and Klebsiella pneumoniae to ceftriaxone and ciprofloxacin.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Resistell AST | The primary endpoint will be the sensitivity of the device in detecting antibiotic susceptibility in blood samples positive for Gram-negative bacteria. | Approximately 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy and Specificity of Resistell AST | Accuracy and specificity of the device will be calculated to test the effectiveness of the device. | Approximately 30 months | 
| Time to Result (TTR) | Time to Result (TTR) from the point the blood culture turns positive for Gram-negative bacteria to the point antibiotic susceptibility results are obtained from the Resistell AST device. | Approximately 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacteremia Sepsis Antibiotic Susceptibility Testing AST Gram-negative, Resistell Phenotech, Nanomotion, Cantilever