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

NCT05002413 | Completed

• 1 other identifier: 2020-01622
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteremia Sepsis

Keywords

Bacteremia Sepsis Antibiotic Susceptibility Testing AST Gram-negative; Resistell Phenotech; Nanomotion; Cantilever

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy and Specificity of Resistell AST

  Approximately 30 months

• Time to Result (TTR)

  Approximately 30 months

Interventions

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.

Also known as: Resistell Antibiotic Susceptibility Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with bacteremia considered to be due to a pathogenic strain who have been hospitalized at CHUV at the time of blood culture inoculation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Resistell AG: lead
• Innosuisse - Swiss Innovation Agency: collaborator

Study Sites (1)

Institut de microbiologie CHUV R , Suisse +41 21 314 4056

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 41173335 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.

  PMID: 36410804 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: June 18, 2021
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)