Carbapenem-Resistant EnterobacteriaceaeNCT03680898
Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.
A study testing Rectal swab collection in people with Carbapenem-Resistant Enterobacteriaceae, run by Meridian Bioscience, Inc. at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae
- What is being tested?
- Rectal swab collection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Feb 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient/sample not meeting inclusion criteria above
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Henry Ford Health System
Detroit, Michigan, 48202
Indiana University and Purdue University Institutions
Indianapolis, Indiana, 46202
Canada1 site
Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex
Toronto, Ontario, M5G 1X5
About this study
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.
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.
Read the 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:
- Sample Buffer Tube (SBT)
- Disposable Transfer Tool (DTT)
- 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
- Being tested
- Rectal swab collection
- Keywords
- Carbapenem, rectal swab, infectious disease, infection
- Medical subject headings
- Communicable Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal swab collectionDevice
Patient will provide a rectal swab by following hospital-provided instructions.
| Study group | Role | What they receive |
|---|---|---|
| revogene Testing | Experimental | The swab will be used for the testing on the revogene using the GenePOC Carba assay. Receives: Device: Rectal swab collection |
| Reference Method | Active comparator | The other swab will be used in the Reference Method. Receives: Device: Rectal swab collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start12 Feb 2019
- Primary completion31 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-Resistant EnterobacteriaceaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Chiasson, PhD, Study director, Meridian Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680898
- Sponsor's protocol ID
- GPC04-003
- Status last verified
- Apr 2021
- First submitted
- 20 Sep 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03680898
- Acronym / sponsor ID
- GPC04-003
- Conditions
- Carbapenem-Resistant Enterobacteriaceae
- Keywords
- Carbapenem, rectal swab, infectious disease, infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sample Buffer Tube (SBT)
- Disposable Transfer Tool (DTT)
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| revogene Testing | Experimental | Device: Rectal swab collectionThe swab will be used for the testing on the revogene using the GenePOC Carba assay. |
| Reference Method | Active comparator | Device: Rectal swab collectionThe other swab will be used in the Reference Method. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient/sample not meeting inclusion criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal swab collectionPatient will provide a rectal swab by following hospital-provided instructions. | Device | Reference Method, revogene Testing |
Primary outcome
Performance characteristics : Clinical sensitivity (true positive rate) in comparison to the Reference Method
Time frame: up to 3 months
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.
Performance characteristics : clinical specificity (true negative rate) in comparison to the Reference Method
Time frame: up to 3 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Chiasson, PhD study director
Meridian Bioscience, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal swab collection in people with Carbapenem-Resistant Enterobacteriaceae, run by Meridian Bioscience, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance characteristics : Clinical sensitivity (true positive rate) in comparison to the Reference Method (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.