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

NCT03680898 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2021-04-30

No results posted yet for this study

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

Interventions

DEVICE

Rectal swab collection

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

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Keith Chiasson, PhD · Meridian Bioscience, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2023-05-31
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03680898 on ClinicalTrials.gov