NCT03680898

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Carbapenem-Resistant Enterobacteriaceae

Interventions

Type	Name	Description
DEVICE	Rectal swab collection	Patient will provide a rectal swab by following hospital-provided instructions.

Timeline

• Start date: 2019-02-12
• Primary completion: 2023-05-31
• Completion: 2023-06-30
• First posted: 2018-09-21
• Last updated: 2021-04-30

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study