Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.

NCT03680898 | Unknown FDA Device

• 1 other identifier: GPC04-003
• Study Type: interventional
• Target: 1,200
• Locations: 2 countries
• Sites: 3

Brief Summary

The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase Producing Organisms (CPOs) in rectal swab samples.

Conditions

Carbapenem-Resistant Enterobacteriaceae

Keywords

Carbapenem; rectal swab; infectious disease; infection

Outcome Measures

Primary Outcomes (2)

• Performance characteristics : Clinical sensitivity (true positive rate) in comparison to the Reference Method

  To establish the performance characteristics of the GenePOC Carba assay for its use in determining the presence of CPO/CPE in rectal swab samples obtained from patients suspected of being infected, or considered at risk. Sensitivity will be estimated as the proportion of positives that are correctly identified by the Carba assay when compared to the Reference Method.

  up to 3 months

• Performance characteristics : clinical specificity (true negative rate) in comparison to the Reference Method

  To establish the performance characteristics of the GenePOC Carba assay for its use in determining the presence of CPO/CPE in rectal swab samples obtained from patients suspected of being infected, or considered at risk. Sensitivity will be estimated as the proportion of positives that are correctly identified by the Carba assay when compared to the Reference Method.

  up to 3 months

Study Arms (2)

revogene Testing

EXPERIMENTAL

The swab will be used for the testing on the revogene using the GenePOC Carba assay.

Device: Rectal swab collection

Reference Method

ACTIVE COMPARATOR

The other swab will be used in the Reference Method.

Device: Rectal swab collection

Interventions

Rectal swab collection DEVICE

Patient will provide a rectal swab by following hospital-provided instructions.

Reference Method; revogene Testing

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Samples from patients who were previously diagnosed to be infected with CPOs, or were identified per hospital policies as being suspected or are at risk for CPO infection;
• Patient that signed the approved Informed Consent Form (if applicable)
• Patient older than 2 years of age (\>24.0 months)
• Only one (1) compliant sample per patient is allowed

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (3)

Indiana University and Purdue University Institutions

Indianapolis, Indiana, 46202, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Communicable Diseases; Infections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Keith Chiasson, PhD

  Meridian Bioscience, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 21, 2018
• Study Start: February 12, 2019
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)