Clinical trial NCT05613322: Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bacteremia Sepsis
Keywords: Antibiotic
Susceptibility
AST
E.coli
K. pneumoniae
Phenotech
Lead sponsor: Resistell AG
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bacteremia considered to be due to E. coli or K. pneumoniae.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of the Resistell Phenotech vs Kirby-Bauer
timeFrame: 18 months
Secondary outcomes:
measure: Specificity and accuracy of the Resistell Phenotech vs Kirby-Bauer
timeFrame: 18 months
measure: Sensitivity, specificity, and accuracy of the Resistell Phenotech vs other comparators
timeFrame: 18 months
measure: Time to result of Resistell Phenotech vs Kirby-Bauer and other comparators
timeFrame: 18 months
measure: Category agreement and discrepancies
timeFrame: 18 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck (MUI), Institut für Hygiene und Medizinische Mikrobiologie
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois (CHUV), Institut de Microbiologie
Study officials:
References: