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

Status unconfirmed · Not applicable

Conditions studied: Carbapenem-Resistant Enterobacteriaceae

In brief

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.

Key facts

Study ID

NCT03680898

Run by

Meridian Bioscience, Inc.

People needed

1200

Starts

2019-02-12

Expected to finish

2023-06-30

Last updated by the study team

2021-04-30

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

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

You may not qualify if…

• Patient/sample not meeting inclusion criteria above

Where it is running

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

Full record on ClinicalTrials.gov

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