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

Completed

• Conditions: Bacteremia Sepsis

• Registration Number: NCT05002413
• Lead Sponsor: Resistell AG

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.

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 Timeline

• Study Start: 2021-06-18
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-12
• Primary Completion: 2024-02-19
• Study Completion: 2024-02-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of Resistell AST	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.

Secondary Outcome Measures

Name	Time	Method
Time to Result (TTR)	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.
Accuracy and Specificity of Resistell AST	Approximately 30 months	Accuracy and specificity of the device will be calculated to test the effectiveness of the device.

Trial Locations

Locations (1)

Institut de microbiologie CHUV R , Suisse +41 21 314 4056; 🇨🇭 Lausanne, Vaud, Switzerland