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

Bacteremia Sepsis Clinical Trial

— NANO-RAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05002413
• Other study ID #: 2020-01622
• Status: Completed
• Start date: June 18, 2021
• Est. completion date: February 19, 2024

Study information

• Verified date: April 2024
• Source: Resistell AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 19, 2024
• Est. primary completion date: February 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Bacteremia Sepsis
• Disease Susceptibility
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Resistell AST
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.

Locations

Country	Name	City	State
Switzerland	Institut de microbiologie CHUV R , Suisse +41 21 314 4056	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Resistell AG	Innosuisse - Swiss Innovation Agency

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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