Institut de microbiologie CHUV R , Suisse +41 21 314 4056
Lausanne, Canton of Vaud, 1011, Switzerland
NCT Number: NCT05002413
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.
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Notify Me18 year and older
All sexes
Observational
Lausanne, Canton of Vaud, 1011, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The patients meeting all the following criteria can be recruited in the study:
Exclusion criteria
The patients meeting any of the following criteria will be excluded from the study:
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.
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.
Other names: Resistell Antibiotic Susceptibility Test
Time frame: 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.
Time frame: Approximately 30 months
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) 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.
Resistell AG
Industry
NANO-RAST: Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis
Acronym: NANO-RAST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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