Clostridium Difficile InfectionNCT02968758
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
A study testing Comparison between GenePOC PCR and Reference Method in people with Clostridium Difficile Infection, run by Meridian Bioscience, Inc. at 7 sites in 2 countries.
Trial summary
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method considered as gold… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Comparison between GenePOC PCR and Reference Method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,461 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 6 Feb 2017to 10 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unformed Stool specimens from patients suspected of having CDI for whom diagnostic tests are indicated and ordered;
- At least 1.25mL of unformed stool specimen (defined as specimen assuming the shape of its container);
- Only one (1) specimen per patient will be included in the study;
- Materials use within their expiration date;
- Transport, storage times, and conditions (e.g. room temperature and/or refrigerated) within requested indications.
Who cannot join
- Specimens from patients for whom CDI diagnostic tests have not been ordered;
- Transport and storage times and conditions that exceed these Study Protocol requirements;
- Formed or hard stool specimens or rectal swabs.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Tricore Laboratory University of New Mexico
Albuquerque, New Mexico, 87102
John Hopkins University School of Medicine
Baltimore, Maryland, 21287
Detroit Medical Center University Laboratories
Detroit, Michigan, 48201
Wishard Health Services
Indianapolis, Indiana, 46202
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Canada2 sites
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex
Toronto, Ontario, M5G 1X5
About this study
Official title: Prospective Multi-Center Study for Clinical Validation of the Molecular-Based GenePOC CDiff System for the Detection of Toxin B Gene From Toxigenic Clostridium Difficile Strains in Unformed (Soft or Liquid) Human Stool Specimens
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method considered as gold standard for detection of toxigenic Clostridium difficile in stool specimens.
Read the detailed description
The GenePOC CDiff test performed on the GenePOC™ instrument is a qualitative in vitro diagnostic (IVD) test that utilizes automated sample preparation and real-time polymerase chain reaction (rtPCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI).
The GenePOC CDiff system comprises the GenePOC instrument and the GenePOC CDiff test, which consists of:
- Transfer Loop (TL)
- CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)
- CDiff Sample Buffer Tube (SBT)
- Disposable Transfer Tool (DTT).
The GenePOC Instrument is fully automated and integrates sample lysis, dilution, amplification and detection of the target sequence in complex samples using real-time Polymerase chain reaction (rtPCR). User intervention is only required for discharging the patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly interface, two barcode readers, and integrated firmware and software to deliver results to the user. The PIE is a closed system that prevents the risk of contamination.
An unformed (soft or liquid) stool specimen is collected using standard stool collection device. Using a disposable 5µL inoculating loop (transfer loop) dipped into the homogenized stool specimen, stool material is transferred into SBT and vortexed. Sample is then transferred to the GenePOC CDiff PIE. The GenePOC CDiff PIE is then automatically processed by the GenePOC Instrument. 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 GenePOC instrument per site will be allocated. The purpose of the clinical investigation is to enroll sufficient specimens from up to 7 Clinical Centers to obtain a total of 150 specimens positive for CDiff based on the Reference Method final result.
Subject Informed consent is not required for this clinical trial as the testing will be performed on excess de-identified specimens only.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Comparison between GenePOC PCR and Reference Method
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between GenePOC PCR and Reference MethodDevice
Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.
| Study group | Role | What they receive |
|---|---|---|
| Accuracy Testing | Experimental | Comparison between GenePOC PCR and Reference Method Receives: Device: Comparison between GenePOC PCR and Reference Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method
To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI).
Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.
Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.
Measured: At the time of the results with Reference Method is confirmed, up to 3 months
Secondary outcomes (3)
Positive and Negative Predictive Values (PPV and NPV)
To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System.
PPV is the percentage of true positives out of all positive results (true positive/true positive + false positive).
NPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.).
Measured: At the time of the results with Reference Method is confirmed, up to 3 months
Unresolved Sample Results
To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).
Measured: At the time of the results with Reference Method is confirmed, up to 3 months
Indeterminate Sample Results
To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).
Measured: At the time of the results with Reference Method is confirmed, 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 Nov 2016 (estimated)
- Study start6 Feb 2017
- Primary completion2 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium Difficile InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrice Allibert, Study director, Meridian Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968758
- Sponsor's protocol ID
- GenePOC CDiff_clinical-01
- Status last verified
- Jan 2019
- First submitted
- 15 Nov 2016
- Last updated
- 3 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center Study for Clinical Validation of the Molecular-Based GenePOC CDiff System for the Detection of Toxin B Gene From Toxigenic Clostridium Difficile Strains in Unformed (Soft or Liquid) Human Stool Specimens
- ClinicalTrials.gov ID
- NCT02968758
- Acronym / sponsor ID
- GenePOC CDiff_clinical-01
- Conditions
- Clostridium Difficile Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,461 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Posted 11 Jan 2019
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 verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method considered as gold standard for detection of toxigenic Clostridium difficile in stool specimens.
Detailed description
The GenePOC CDiff test performed on the GenePOC™ instrument is a qualitative in vitro diagnostic (IVD) test that utilizes automated sample preparation and real-time polymerase chain reaction (rtPCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI).
The GenePOC CDiff system comprises the GenePOC instrument and the GenePOC CDiff test, which consists of:
- Transfer Loop (TL)
- CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)
- CDiff Sample Buffer Tube (SBT)
- Disposable Transfer Tool (DTT).
The GenePOC Instrument is fully automated and integrates sample lysis, dilution, amplification and detection of the target sequence in complex samples using real-time Polymerase chain reaction (rtPCR). User intervention is only required for discharging the patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly interface, two barcode readers, and integrated firmware and software to deliver results to the user. The PIE is a closed system that prevents the risk of contamination.
An unformed (soft or liquid) stool specimen is collected using standard stool collection device. Using a disposable 5µL inoculating loop (transfer loop) dipped into the homogenized stool specimen, stool material is transferred into SBT and vortexed. Sample is then transferred to the GenePOC CDiff PIE. The GenePOC CDiff PIE is then automatically processed by the GenePOC Instrument. 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 GenePOC instrument per site will be allocated. The purpose of the clinical investigation is to enroll sufficient specimens from up to 7 Clinical Centers to obtain a total of 150 specimens positive for CDiff based on the Reference Method final result.
Subject Informed consent is not required for this clinical trial as the testing will be performed on excess de-identified specimens only.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accuracy Testing | Experimental | Device: Comparison between GenePOC PCR and Reference MethodComparison between GenePOC PCR and Reference Method |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Unformed Stool specimens from patients suspected of having CDI for whom diagnostic tests are indicated and ordered;
- At least 1.25mL of unformed stool specimen (defined as specimen assuming the shape of its container);
- Only one (1) specimen per patient will be included in the study;
- Materials use within their expiration date;
- Transport, storage times, and conditions (e.g. room temperature and/or refrigerated) within requested indications.
Key exclusion criteria (3 listed)
- Specimens from patients for whom CDI diagnostic tests have not been ordered;
- Transport and storage times and conditions that exceed these Study Protocol requirements;
- Formed or hard stool specimens or rectal swabs.
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 |
|---|---|---|
| Comparison between GenePOC PCR and Reference MethodStool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain. | Device | Accuracy Testing |
Primary outcome
Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method
Time frame: At the time of the results with Reference Method is confirmed, up to 3 months
To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI). Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method. Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.
3 secondary outcomes
Positive and Negative Predictive Values (PPV and NPV)
Time frame: At the time of the results with Reference Method is confirmed, up to 3 months
Unresolved Sample Results
Time frame: At the time of the results with Reference Method is confirmed, up to 3 months
Indeterminate Sample Results
Time frame: At the time of the results with Reference Method is confirmed, up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Patrice Allibert study director
Meridian Bioscience, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison between GenePOC PCR and Reference Method in people with Clostridium Difficile Infection, run by Meridian Bioscience, Inc. at 7 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 11 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method (time frame: At the time of the results with Reference Method is confirmed, up to 3 months). 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 3 May 2021.