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

NCT05613322 | Terminated

• 1 other identifier: PHENOTECH-1
• Study Type: observational
• Target: 246
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Bacteremia Sepsis

Keywords

Antibiotic; Susceptibility; AST; E.coli; K. pneumoniae; Phenotech

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Specificity and accuracy of the Resistell Phenotech vs Kirby-Bauer

  18 months

• Sensitivity, specificity, and accuracy of the Resistell Phenotech vs other comparators

  18 months

• Time to result of Resistell Phenotech vs Kirby-Bauer and other comparators

  18 months

• Category agreement and discrepancies

  18 months

Interventions

Resistell Phenotech DIAGNOSTIC_TEST

Resistell Phenotech IVD device used to assess susceptibility of Gram negative bacteria to antibiotics.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with bacteremia considered to be due to E. coli or K. pneumoniae.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Resistell AG: lead

Study Sites (3)

Medizinische Universität Innsbruck (MUI), Institut für Hygiene und Medizinische Mikrobiologie

Innsbruck, Innsbruck, 6020, Austria

Location

Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)

Madrid, Madrid, 28034, Spain

Location

Centre hospitalier universitaire vaudois (CHUV), Institut de Microbiologie

Lausanne, Lausanne, 1011, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacteria extracted from blood and tested with the investigational device.

MeSH Terms

Conditions

Disease Susceptibility; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: January 18, 2023
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

ES (1); AU (1); CH (1)