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

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

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.

Study Overview

• Status: Completed
• Conditions: Bacteremia Sepsis
• Intervention / Treatment: Diagnostic test: Resistell AST

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

• Study Contact: Name: Danuta Cichocka, Dr; Phone Number: 0041 798999188; Email: danuta.cichocka@resistell.com
• Study Contact Backup: Name: Clara Orlando, Dr; Phone Number: 00417959481329; Email: clara.orlando@resistell.com

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Institut de microbiologie CHUV R , Suisse +41 21 314 4056

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Approximately 30 months

Collaborators and Investigators

• Sponsor: Resistell AG
• Collaborators: Innosuisse - Swiss Innovation Agency

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Actual): February 19, 2024
• Study Completion (Actual): February 19, 2024

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Bacteremia Sepsis Antibiotic Susceptibility Testing AST Gram-negative; Resistell Phenotech; Nanomotion; Cantilever
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Toxemia; Bacteremia; Disease Susceptibility; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2020-01622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No