UnknownNot Applicable

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

United States, Canada1,200 participantsStarted 2019-02-12

Plain-language 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.

Who can participate

Age range2 Years

SexALL

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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

What they're measuring

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

Timeframe: up to 3 months

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

Timeframe: up to 3 months

Trial details

NCT IDNCT03680898

SponsorMeridian Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More Carbapenem-Resistant Enterobacteriaceae trials