Clinical Performance of the Checkable Medical At-Home Strep A Test
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05107362 |
|
Recruitment Status :
Recruiting
First Posted : November 4, 2021
Last Update Posted : March 10, 2023
|
Sponsor:
Checkable Medical Inc
Collaborator:
Curebase Inc.
Information provided by (Responsible Party):
Checkable Medical Inc
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief 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 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Streptococcus Pyogenes Infection Pharyngitis Respiratory Tract Infections | Diagnostic Test: untrained lay user performs investigational diagnostic test |
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 Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Clinical Performance of the Checkable Medical At-Home Strep A Test |
| Actual Study Start Date : | December 21, 2021 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | July 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Streptococcal Infections
| Group/Cohort | Intervention/treatment |
|---|---|
|
Symptomatic Adult and Pediatric Subjects
Untrained lay user to collect throat swab specimen and perform investigational test.
|
Diagnostic Test: untrained lay user performs investigational diagnostic 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. |
Primary Outcome Measures :
- 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 (-).
Secondary Outcome Measures :
- Negative Predictive Value [ Time Frame: 1 day ]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).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
1. Lay users who are accompanying patients are unwilling/unable to collect throat swab sample from a child or adult.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05107362
Contacts
| Contact: Marla McIntyre | 701-446-7907 | marla@checkablemedical.com | |
| Contact: Cheryl A Hodges-Savola, PhD | 651-686-9075 | cheryl.savola@checkablemedical.com |
Locations
Show 22 study locations
Sponsors and Collaborators
Checkable Medical Inc
Curebase Inc.
Investigators
| Study Director: | Marla McIntyre | Checkable Medical |
| Responsible Party: | Checkable Medical Inc |
| ClinicalTrials.gov Identifier: | NCT05107362 |
| Other Study ID Numbers: |
CM-003 |
| First Posted: | November 4, 2021 Key Record Dates |
| Last Update Posted: | March 10, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Checkable Medical Inc:
|
In vitro diagnostic |
Additional relevant MeSH terms:
|
Infections Communicable Diseases Respiratory Tract Infections Pharyngitis Disease Attributes |
Pathologic Processes Respiratory Tract Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |