Resistell Phenotech AST to Determine the Antibiotic Susce... | NCT05613322

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

NCT05613322

Sponsor

Resistell AG

Status

Terminated

Last Update Posted

Oct 26, 2024Actual

Enrollment

246Actual

Phase

Not provided

Conditions

Bacteremia Sepsis

Interventions

Resistell Phenotech

Countries

Austria
Spain
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Statistical power for primary endpoint (sensitivity) for E. coli and K. pneumoniae and ceftriaxone was achieved

Expanded Access Info

Start Date

Jan 18, 2023Actual

Primary Completion Date

Sep 5, 2024Actual

Completion Date

Sep 5, 2024Actual

First Submitted Date

Nov 4, 2022

First Submission Date that Met QC Criteria

Nov 4, 2022

First Posted Date

Nov 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2024

Last Update Posted Date

Oct 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

246Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistell Phenotech	Diagnostic Test	Resistell Phenotech IVD device used to assess susceptibility of Gram negative bacteria to antibiotics.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Universität Innsbruck (MUI), Institut für Hygiene und Medizinische Mikrobiologie		Innsbruck	Innsbruck	6020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004198	Disease Susceptibility
D004927	Escherichia coli Infections

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D004756	Enterobacteriaceae Infections

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Browse Branches

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