Clinical trial NCT03680898: Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carbapenem-Resistant Enterobacteriaceae
Keywords: Carbapenem
rectal swab
infectious disease
infection
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance characteristics : Clinical sensitivity (true positive rate) in comparison to the Reference Method
timeFrame: up to 3 months
measure: Performance characteristics : clinical specificity (true negative rate) in comparison to the Reference Method
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University and Purdue University Institutions
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Toronto
country: Canada
facility: Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex
state: Ontario
Study officials:
affiliation: Meridian Bioscience, Inc.
name: Keith Chiasson, PhD
role: STUDY_DIRECTOR
References: