Streptococcus Pyogenes InfectionNCT05107362
Clinical Performance of the Checkable Medical At-Home Strep A Test
An observational study of Streptococcus Pyogenes Infection and Pharyngitis, run by Checkable Medical Inc at 22 sites in United States.
Trial summary
The Checkable Medical At-Home Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Strep (GAS) antigens from throat swabs. The purpose of the study is to evaluate the clinical performance of the investigational device (i.e., sensitivity, specificity, NPV and PPV) when used by… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Streptococcus Pyogenes Infection, Pharyngitis, Respiratory Tract Infections
- What is being tested?
- untrained lay user performs investigational diagnostic test
- How many people
- 1,347 participants
- Where
- 22 sitesUnited States
- Study dates
- 21 Dec 2021to 10 Jul 2023
- Phase
- Observational
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 610 to 1,220 male and female subjects in the US, with approximately 183 subjects being strep positive, are expected to participate in the study. At least half of the subjects will be between 5 and 17 years of age and the remaining subjects will be adults 18 years of age and older.
Who may be able to join
- Subjects seeking medical care for two or more of the following signs/symptoms of pharyngeal streptococcal infections:
- pharyngeal pain [with or without swallowing],
- tonsillar swelling with exudates,
- pharyngeal erythema,
- tender cervical lymphadenopathy,
- fever.
- Subjects who have not received antibiotic treatment within the past 14 days.
- Subjects (or their parents/guardians) provide written informed consent/assent to participate in the study
Who cannot join
- 1. Lay users who are accompanying patients are unwilling/unable to collect throat swab sample from a child or adult.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Robertson Pediatrics
Beverly Hills, California, 90211
Elite Clinical Trials
Blackfoot, Idaho, 83221
Waggoner Pediatrics
Clive, Iowa, 50325
Axis Clinicals
Dilworth, Minnesota, 56529
AFC Urgent Care
Easley, South Carolina, 29640
Infinitive Bio Research
Edison, New Jersey, 08817
Plains Clinical Research
Fargo, North Dakota, 58104
Tribe Clinical Research
Greenville, South Carolina, 29607
Pediatric Associates
Houston, Texas, 77087
Santa Clara Family Clinic
Houston, Texas, 77087
Angel Kids Pediatrics
Jacksonville, Florida, 32225
WellNow Urgent Care and Research
Kalamazoo, Michigan, 49048
MDFirst
Lancaster, South Carolina, 29720
WellNow Urgent Care and Research
Lorain, Ohio, 44053
L&A Morales Health Care
Miami, Florida, 33142
WellNow Urgent Care and Research
Milford, Ohio, 45150
Trinity Health
Minot, North Dakota, 58701
Pediatric Center
Richmond, Texas, 77469
Twelve Corners Pediatrics
Rochester, New York, 14618
AFC Urgent Care
The Bronx, New York, 10465
North Houston Internal Medicine and Pediatric Clinic
Tomball, Texas, 77375
WellNow Urgent Care and Research
Troy, Ohio, 45373
About this study
The Checkable Medical At-Home Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Strep (GAS) antigens from throat swabs. The purpose of the study is to evaluate the clinical performance of the investigational device (i.e., sensitivity, specificity, NPV and PPV) when used by untrained lay persons to detect the presence of Group A Streptococcal antigens in throat swab specimens from individuals five years of age and older with signs and symptoms of pharyngitis, such as fever and sore throat.
Read the detailed description
The study is a prospective, consecutive, non-interventional multicenter study to evaluate the clinical performance of the Checkable Medical At-Home Strep A Test when the test is performed by non-trained adult lay users.
- Patients or parents/legal guardians of patients presenting with signs and symptoms of pharyngeal GAS infections will be recruited at primary care or urgent care clinics.
- Informed consent will be obtained from adult subjects and from the parents/guardians of pediatric subjects. Pediatric subjects 7 years of age or greater will be asked for their assent.
- The lay user will be provided with a Checkable Medical At-Home Strep A Test kit. The user and patient will be provided with a quiet, private space where the user can collect the throat swab specimen and perform the investigational test.
- Once the lay user has collected the swab sample for the Checkable Medical At-Home Strep A Test and performed the test, she/he will document the test result. The Checkable Medical At-Home Strep A Test result is not to be shared with members of the site team who are providing healthcare to the subject.
- When all sample collection, testing and interpretation activities related to the investigational test are completed, a healthcare provider at the study site will collect two additional swab samples. One of these samples will be sent to a central lab where it will be cultured for GAS. An additional sample will be tested using the organization's standard of care (SOC) rapid Strep A test.
- Subjects will be diagnosed and treated in accordance with routine SOC which may include an FDA-cleared rapid GAS test. The Checkable Medical At-Home Strep A Test will not be used to diagnose or treat study subjects.
- This study will take place in at least six sites in at least three different regions of the United States.
- The results from the Checkable Medical At-Home Strep A Test will be used to compare with the diagnostic truth obtained through culture to compute diagnostic accuracy parameters including sensitivity, NPV, specificity and PPV.
- Being tested
- untrained lay user performs investigational diagnostic test
- Keywords
- In vitro diagnostic
- Medical subject headings
- Streptococcal Infections, Pharyngitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
untrained lay user performs investigational diagnostic testDiagnostic test
Untrained lay users (parents/guardians of pediatric subjects or friends/family members of adult subjects) collect throat swab specimens and perform the investigational diagnostic test.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic Adult and Pediatric Subjects | Untrained lay user to collect throat swab specimen and perform investigational test. Receives: Diagnostic Test: untrained lay user performs investigational diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Sensitivity and Clinical Specificity
Sensitivity is the proportion of subjects with a positive bacterial culture that are also positive in the investigational Strep A test (+).
Specificity is the proportion of subjects with a negative bacterial culture that are also negative in the investigational Strep A test (-).
Measured: 1 day
Secondary outcomes (1)
Negative Predictive Value
Negative Predictive Value (NPV) is the proportion of subjects with negative investigational Strep A test results who also have negative cultures (diagnostic truth); calculated as 100 x d/(c+d).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start21 Dec 2021
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Pyogenes 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Checkable Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Responsible party
- Sponsor
- Investigators
- Marla McIntyre, Study director, Checkable Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107362
- Sponsor's protocol ID
- CM-003
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2021
- Last updated
- 12 Jul 2023
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Checkable Medical At-Home Strep A Test
- ClinicalTrials.gov ID
- NCT05107362
- Acronym / sponsor ID
- CM-003
- Keywords
- In vitro diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,347 participants (actual)
- Lead sponsor
- Checkable Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 4 Nov 2021 (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 Checkable Medical At-Home Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Strep (GAS) antigens from throat swabs. The purpose of the study is to evaluate the clinical performance of the investigational device (i.e., sensitivity, specificity, NPV and PPV) when used by untrained lay persons to detect the presence of Group A Streptococcal antigens in throat swab specimens from individuals five years of age and older with signs and symptoms of pharyngitis, such as fever and sore throat.
Detailed description
The study is a prospective, consecutive, non-interventional multicenter study to evaluate the clinical performance of the Checkable Medical At-Home Strep A Test when the test is performed by non-trained adult lay users.
- Patients or parents/legal guardians of patients presenting with signs and symptoms of pharyngeal GAS infections will be recruited at primary care or urgent care clinics.
- Informed consent will be obtained from adult subjects and from the parents/guardians of pediatric subjects. Pediatric subjects 7 years of age or greater will be asked for their assent.
- The lay user will be provided with a Checkable Medical At-Home Strep A Test kit. The user and patient will be provided with a quiet, private space where the user can collect the throat swab specimen and perform the investigational test.
- Once the lay user has collected the swab sample for the Checkable Medical At-Home Strep A Test and performed the test, she/he will document the test result. The Checkable Medical At-Home Strep A Test result is not to be shared with members of the site team who are providing healthcare to the subject.
- When all sample collection, testing and interpretation activities related to the investigational test are completed, a healthcare provider at the study site will collect two additional swab samples. One of these samples will be sent to a central lab where it will be cultured for GAS. An additional sample will be tested using the organization's standard of care (SOC) rapid Strep A test.
- Subjects will be diagnosed and treated in accordance with routine SOC which may include an FDA-cleared rapid GAS test. The Checkable Medical At-Home Strep A Test will not be used to diagnose or treat study subjects.
- This study will take place in at least six sites in at least three different regions of the United States.
- The results from the Checkable Medical At-Home Strep A Test will be used to compare with the diagnostic truth obtained through culture to compute diagnostic accuracy parameters including sensitivity, NPV, specificity and PPV.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Adult and Pediatric Subjects | – | Diagnostic Test: untrained lay user performs investigational diagnostic testUntrained lay user to collect throat swab specimen and perform investigational test. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 610 to 1,220 male and female subjects in the US, with approximately 183 subjects being strep positive, are expected to participate in the study. At least half of the subjects will be between 5 and 17 years of age and the remaining subjects will be adults 18 years of age and older.
Key inclusion criteria (8 listed)
- Subjects seeking medical care for two or more of the following signs/symptoms of pharyngeal streptococcal infections:
- Subjects who have not received antibiotic treatment within the past 14 days.
- Subjects (or their parents/guardians) provide written informed consent/assent to participate in the study
Key exclusion criteria (1 listed)
- 1. Lay users who are accompanying patients are unwilling/unable to collect throat swab sample from a child or adult.
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 |
|---|---|---|
| untrained lay user performs investigational diagnostic testUntrained lay users (parents/guardians of pediatric subjects or friends/family members of adult subjects) collect throat swab specimens and perform the investigational diagnostic test. | Diagnostic test | Symptomatic Adult and Pediatric Subjects |
Primary outcome
Clinical Sensitivity and Clinical Specificity
Time frame: 1 day
Sensitivity is the proportion of subjects with a positive bacterial culture that are also positive in the investigational Strep A test (+). Specificity is the proportion of subjects with a negative bacterial culture that are also negative in the investigational Strep A test (-).
1 secondary outcome
Negative Predictive Value
Time frame: 1 day
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 12 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Streptococcus Pyogenes Infection
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruitingPhase 1
Stopping Strep Throat With Antibodies in Healthy Adults.
Streptococcal Pharyngitis
Not yet recruitingObservational study
Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
Atopic Dermatitis (AD), Scabies
RecruitingPhase 1
A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Strep A Vaccine With Aluminum Hydroxide (Alum) or AS37 in Healthy Young Adults
Streptococcal Infections
RecruitingPhase 1
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults
Group A Streptococcal Infection
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.
Marla McIntyre study director
Checkable Medical
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pyogenes Infection and Pharyngitis, run by Checkable Medical Inc at 22 sites in United States.
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 8 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. 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?
Clinical Sensitivity and Clinical Specificity (time frame: 1 day). 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 12 Jul 2023.