Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia (PHENOTECH-1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bacteremia Sepsis
• Intervention / Treatment: Diagnostic test: Resistell Phenotech

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Resistell AG; Phone Number: +41 79 899 91 88; Email: clinops@resistell.com

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medizinische Universität Innsbruck (MUI), Institut für Hygiene und Medizinische Mikrobiologie
    • Contact: Cornelia Lass-Flörl, Prof. Dr.; Email: cornelia.lass-floerl@i-med.ac.at
    • Principal Investigator: Cornelia Lass-Flörl, Prof. Dr.
    • Sub-Investigator: Ronald Gstir, Dr.
• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
    • Contact: Rafael Cantón, Prof. Dr.; Email: rafael.canton@salud.madrid.org
    • Principal Investigator: Rafael Cantón, Prof. Dr.
• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Centre hospitalier universitaire vaudois (CHUV), Institut de Microbiologie
    • Contact: Gilbert Greub, Prof. Dr.; Email: gilbert.greub@chuv.ch
    • Principal Investigator: Gilbert Greub, Prof. Dr.

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 E. coli or K. pneumoniae.

Description

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

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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Resistell AG

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 14, 2022

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: Antibiotic; E.coli; Susceptibility; AST; K. pneumoniae; Phenotech
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Disease Susceptibility
• Other Study ID Numbers: PHENOTECH-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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