Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia

Bacteremia Sepsis Clinical Trial

— PHENOTECH-1  

Official title:

Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia: a Prospective, Non-interventional, Multi-centric, Clinical Performance Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613322
• Other study ID #: PHENOTECH-1
• Status: Recruiting
• Start date: January 18, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Resistell AG
• Contact: Resistell AG
• Phone: +41 79 899 91 88
• Email: clinops[@]resistell.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K. pneumoniae) to clinically relevant antibiotics. The study is designed as a prospective, non-interventional, multi-center, single-arm study. The blood culture samples from bacteremia patients that are positive for E. coli or K. pneumoniae will be tested with the Resistell Phenotech device after strain identification by MALDI-TOF. The results of the Resistell AST will be compared with the results from the disk diffusion tests (all sites use the Kirby-Bauer disk diffusion test), and site dependent tests (VITEK® 2, BD Phoenix™, MicroScan WalkAway system, and/or EUCAST RAST), which are currently the standard AST methods in the microbiology laboratories at the participating sites.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have signed a General Consent form approving use of their residual blood samples for research purposes (applicable at CHUV only)
• Patients who have signed a consent allowing the use of their residual sample (Restprobenerklärung) (applicable at MUI, only)
• Patients over the age of 18 years (>18)
• Patients with bacteremia considered to be due to E. coli or K. pneumoniae
• Patients whose positive blood cultures were not older than 24 hours at the time of AST start

Exclusion Criteria:

• Patients with documented refusal of the use of biological material for research purposes (applicable at CHUV, only)
• Patients with polymicrobial bacteremia

Related Conditions & MeSH terms

• Bacteremia
• Bacteremia Sepsis
• Disease Susceptibility

Intervention

Diagnostic Test:
• Resistell Phenotech
Resistell Phenotech IVD device used to assess susceptibility of Gram negative bacteria to antibiotics.

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck (MUI), Institut für Hygiene und Medizinische Mikrobiologie	Innsbruck
Spain	Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)	Madrid
Switzerland	Centre hospitalier universitaire vaudois (CHUV), Institut de Microbiologie	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Resistell AG

Countries where clinical trial is conducted

Austria,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the Resistell Phenotech vs Kirby-Bauer	To assess the sensitivity of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to the gold standard Kirby-Bauer disk diffusion test.	18 months
Secondary	Specificity and accuracy of the Resistell Phenotech vs Kirby-Bauer	To assess the specificity and accuracy of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to the gold standard Kirby-Bauer disk diffusion test.	18 months
Secondary	Sensitivity, specificity, and accuracy of the Resistell Phenotech vs other comparators	To assess the sensitivity, specificity, and accuracy of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to other routine diagnostic AST tests run at each site	18 months
Secondary	Time to result of Resistell Phenotech vs Kirby-Bauer and other comparators	To assess the difference between time to result (TTR) of Resistell Phenotech and the TTR of the Kirby-Bauer and the other routine diagnostic AST methods run at each site.	18 months
Secondary	Category agreement and discrepancies	To assess category agreement (CA), very major discrepancy (VMD), major discrepancy (MD) of the results obtained with Resistell Phenotech compared to the Kirby-Bauer and the other routine diagnostic AST test results at each site	18 months