Bacteremia Sepsis
Conditions
Keywords
Bacteremia Sepsis Antibiotic Susceptibility Testing AST Gram-negative, Resistell Phenotech, Nanomotion, Cantilever
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTResistell 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.
Sponsors
Innosuisse - Swiss Innovation Agency
Resistell AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Resistell AST | Approximately 30 months | The primary endpoint will be the sensitivity of the device in detecting antibiotic susceptibility in blood samples positive for Gram-negative bacteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy and Specificity of Resistell AST | Approximately 30 months | Accuracy and specificity of the device will be calculated to test the effectiveness of the device. |
| Time to Result (TTR) | Approximately 30 months | 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. |
Countries
Switzerland
Outcome results
None listed