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.
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.
Study Type
OBSERVATIONAL
Enrollment
300
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.
Institut de microbiologie CHUV R , Suisse +41 21 314 4056
Lausanne, Canton of Vaud, Switzerland
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.
Time frame: Approximately 30 months
Accuracy and Specificity of Resistell AST
Accuracy and specificity of the device will be calculated to test the effectiveness of the device.
Time frame: 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.
Time frame: Approximately 30 months
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