NCT05613322

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 246 (actual)
• Sponsor: Resistell AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Resistell Phenotech	Resistell Phenotech IVD device used to assess susceptibility of Gram negative bacteria to antibiotics.

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2022-11-14
• Last updated: 2024-10-26

Locations

3 sites across 3 countries: Austria, Spain, Switzerland