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

Prospective Study for Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes of Gram-negative Bacteria (blaIMP, blaKPC, blaNDM, blaOXA-48-like and blaVIM) in Rectal Swab Samples From Patients Suspected of Being Colonized. The Targeted Organisms Are Enterobacteriaceae, Acinetobacter Baumannii, and Pseudomonas Aeruginosa.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carbapenem-Resistant Enterobacteriaceae
• Intervention / Treatment: Device: Rectal swab collection

Detailed Description

The GenePOC Carba assay will be performed using the revogene instrument. The revogene instrument, used in conjunction with appropriate reagents, is capable of automated cell lysis, dilution of nucleic acids from multiple sample types as well as automated amplification and detection of target nucleic acid sequences.

The GenePOC Carba assay reagents kits consist of:

1. Sample Buffer Tube (SBT)
2. Disposable Transfer Tool (DTT)
3. Disposable microfluidic cartridges (PIE)

The test is performed using the revogene™. The revogene automates sample homogenization, sample dilution, cells lysis, DNA amplification, and detection of the amplified PCR products. User intervention is only required for discharging the patient sample into the Sample Buffer Tube (SBT), transferring the sample into the PIE, and loading/unloading the PIEs into the revogene carousel.

A dual swab sample is collected when ICF is signed by patient. One of the swab is transferred into the SBT and vortexed. Sample is then transferred to the GenePOC Carba PIE. The PIE is then automatically processed by the revogene. On completion of a run, the user removes the processed PIEs from the instrument and discards them according to local biological waste management procedures.

One revogene will be allocated per site. The purpose of this clinical trial is to enroll sufficient patients from up to 14 Clinical Centers to meet regulatory requirements, based on the Reference Method final results.

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University and Purdue University Institutions
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient/sample not meeting inclusion criteria above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: revogene Testing; The swab will be used for the testing on the revogene using the GenePOC Carba assay.	Device: Rectal swab collection; Patient will provide a rectal swab by following hospital-provided instructions.
Active Comparator: Reference Method; The other swab will be used in the Reference Method.	Device: Rectal swab collection; Patient will provide a rectal swab by following hospital-provided instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.
• Investigators: Study Director: Keith Chiasson, PhD, Meridian Bioscience, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: infection; infectious disease; Carbapenem; rectal swab
• Other Study ID Numbers: GPC04-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No