Pharyngitis, InfectiveNCT03422341
Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
A study testing Comparison between GenePOC CR and Reference Method in people with Pharyngitis, Infective, run by Meridian Bioscience, Inc. at 8 sites in 2 countries.
Trial summary
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus… Read more about this study
- Who is it for?
- Ages 25 months and older
- Conditions the study is for
- Pharyngitis, Infective
- What is being tested?
- Comparison between GenePOC CR and Reference Method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 497 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 14 Feb 2018to 11 Jul 2018
- 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 25 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Samples from patients suspected of having signs and symptoms of a pharyngitis infection
- Patient that signed the approved Informed Consent Form (if applicable)
- Patient older than 2 years of age
- Only one (1) compliant sample per patient is allowed
- Use of dual swab with either liquid Stuart or liquid Amies transport Medium
Who cannot join
- Patient/sample not meeting inclusion criteria above
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
Detroit Medical Center University Laboratories
Detroit, Michigan, 48201
Wishard Health Services
Indianapolis, Indiana, 46202
Children's Mercy Hospital
Kansas City, Missouri, 64108
Valley Children's Hospital
Madera, California, 93636
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Canada3 sites
Centre de Recherche Saint-Louis
Québec, Quebec, G1W 4R4
Mount Sinai Services
Toronto, Ontario, M5G 1Z5
BC Children's and Women's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: Prospective Study for Clinical Validation of the Molecular-Based GenePOC Strep A, C/G Assay for the Detection and Identification of Group A β-hemolytic Streptococcus (Streptococcus Pyogenes) and Pyogenic Group C and G β-hemolytic Streptococcus (Streptococcus Dysgalactiae Subsp. Equisimilis) Nucleic Acids From Throat Swab Samples Obtained From Patients With Signs and Symptoms of Pharyngitis.
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.
Read the detailed description
The GenePOC Strep A, C/G 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.
A dual swab sample is collected when ICF is signed by patient. One of the swab will be tested on the revogene™, and the second swab will be tested with standard microbiology method at a Reference Center.
- Conditions
- Pharyngitis, Infective
- Being tested
- Comparison between GenePOC CR and Reference Method
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between GenePOC CR and Reference MethodDevice
The collected swab will be tested with both the GenePOC Strep A, C/G assay and the Reference Method defined as standard microbiology culture and strain identification using a MALDI TOF.
| Study group | Role | What they receive |
|---|---|---|
| GenePOC testing | Experimental | The swab will be used for the testing on the revogene using the GenePOC Strep A, C/G assay.
Intervention will be the Comparison between GenePOC CR and Reference Method. Receives: Device: Comparison between GenePOC CR and Reference Method |
| Reference Method | Active comparator | The swab will be used to detect the presence or absence of Strep A, C/G using standard microbiology method.
Intervention will be the Comparison between GenePOC CR and Reference Method. Receives: Device: Comparison between GenePOC CR and Reference Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance characteristics of the GenePOC Streap A, C/G assay
To establish the performance characteristics of the GenePOC Strep A, C/G assay for its use in determining the presence of Strep A, C/G in throat swab samples obtained from patients with signs and symptoms of pharyngitis infection.
- Sensitivity will be estimated as the proportion of positives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method.
- Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method.
Measured: Up to 14 months
Secondary outcomes (3)
Positive and Negative Predictive Values (PPV and NPV)
To establish the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC Strep A, C/G assay.
PPV will be calculated as the proportion of positive results with the GenePOC Strep A, C/G assay that are true positive results when compared to the Reference Method.
NPV will be calculated as the proportion of negative results with the GenePOC Strep A, C/G assay that are true negative results when compared to the Reference Method.
Measured: Up to 14 months
Unresolved sample results
To establish the rate of unresolved results for the GenePOC Strep A, C/G assay due to sample processing control failure (unresolved sample results).
Measured: Up to 14 months
Indeterminate sample results
To establish the rate of indeterminate results for the GenePOC Strep A, C/G assay due to an instrument failure (indeterminate results).
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start14 Feb 2018
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharyngitis, InfectiveStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 497 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
- NCT03422341
- Sponsor's protocol ID
- GPC03-002
- Status last verified
- Jun 2019
- First submitted
- 23 Jan 2018
- Last updated
- 4 May 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 4 May 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 Strep A, C/G Assay for the Detection and Identification of Group A β-hemolytic Streptococcus (Streptococcus Pyogenes) and Pyogenic Group C and G β-hemolytic Streptococcus (Streptococcus Dysgalactiae Subsp. Equisimilis) Nucleic Acids From Throat Swab Samples Obtained From Patients With Signs and Symptoms of Pharyngitis.
- ClinicalTrials.gov ID
- NCT03422341
- Acronym / sponsor ID
- GPC03-002
- Conditions
- Pharyngitis, Infective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 5 Feb 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 Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.
Detailed description
The GenePOC Strep A, C/G 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.
A dual swab sample is collected when ICF is signed by patient. One of the swab will be tested on the revogene™, and the second swab will be tested with standard microbiology method at a Reference Center.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GenePOC testing | Experimental | Device: Comparison between GenePOC CR and Reference MethodThe swab will be used for the testing on the revogene using the GenePOC Strep A, C/G assay. Intervention will be the Comparison between GenePOC CR and Reference Method. |
| Reference Method | Active comparator | Device: Comparison between GenePOC CR and Reference MethodThe swab will be used to detect the presence or absence of Strep A, C/G using standard microbiology method. Intervention will be the Comparison between GenePOC CR and Reference Method. |
Who may qualify
- Ages
- 25 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Samples from patients suspected of having signs and symptoms of a pharyngitis infection
- Patient that signed the approved Informed Consent Form (if applicable)
- Patient older than 2 years of age
- Only one (1) compliant sample per patient is allowed
- Use of dual swab with either liquid Stuart or liquid Amies transport Medium
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 |
|---|---|---|
| Comparison between GenePOC CR and Reference MethodThe collected swab will be tested with both the GenePOC Strep A, C/G assay and the Reference Method defined as standard microbiology culture and strain identification using a MALDI TOF. | Device | GenePOC testing, Reference Method |
Primary outcome
Performance characteristics of the GenePOC Streap A, C/G assay
Time frame: Up to 14 months
To establish the performance characteristics of the GenePOC Strep A, C/G assay for its use in determining the presence of Strep A, C/G in throat swab samples obtained from patients with signs and symptoms of pharyngitis infection. * Sensitivity will be estimated as the proportion of positives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method. * Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method.
3 secondary outcomes
Positive and Negative Predictive Values (PPV and NPV)
Time frame: Up to 14 months
Unresolved sample results
Time frame: Up to 14 months
Indeterminate sample results
Time frame: Up to 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
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.
8 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 CR and Reference Method in people with Pharyngitis, Infective, run by Meridian Bioscience, Inc. at 8 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 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: finished, as of the sponsor's last update on 4 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 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of the GenePOC Streap A, C/G assay (time frame: Up to 14 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 4 May 2021.