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

Carbapenem-Resistant Enterobacteriaceae Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03680898
• Other study ID #: GPC04-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2021
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carbapenem-Resistant Enterobacteriaceae

Intervention

Device:
• Rectal swab collection
Patient will provide a rectal swab by following hospital-provided instructions.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex	Toronto	Ontario
United States	Henry Ford Health System	Detroit	Michigan
United States	Indiana University and Purdue University Institutions	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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