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| Name | Class |
|---|---|
| Innosuisse - Swiss Innovation Agency | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistell AST | Diagnostic Test | 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. |
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| 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 |
| 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. |
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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.
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Patients with bacteremia considered to be due to a pathogenic strain who have been hospitalized at CHUV at the time of blood culture inoculation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de microbiologie CHUV R , Suisse +41 21 314 4056 | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41173335 | Derived | Caruana G, Kritikos A, Vocat A, Tagini F, Delfino A, Luraschi A, Delarze E, Marta PV, Delaloye J, Jacot D, Winnicki J, Orlando C, Sturm A, Jozwiak G, Cichocka D, Greub G. Nanomotion-based technology for rapid antibiotic susceptibility testing among adult patients admitted to a tertiary-care hospital with Gram-negative bacteraemia: a prospective, single arm, comparative diagnostic accuracy study. Clin Microbiol Infect. 2026 Feb;32(2):299-305. doi: 10.1016/j.cmi.2025.10.016. Epub 2025 Oct 29. | |
| 36410804 |
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| Approximately 30 months |
| Derived |
| Caruana G, Kritikos A, Vocat A, Luraschi A, Delarze E, Sturm A, Pla Verge M, Jozwiak G, Kushwaha S, Delaloye J, Cichocka D, Greub G. Investigating nanomotion-based technology (Resistell AST) for rapid antibiotic susceptibility testing among adult patients admitted to a tertiary-care hospital with Gram-negative bacteraemia: protocol for a prospective, observational, cross-sectional, single-arm study. BMJ Open. 2022 Nov 21;12(11):e064016. doi: 10.1136/bmjopen-2022-064016. |