Clinical Performance of the Checkable Medical At-Home Strep A Test
NCT ID: NCT05107362
Last Updated: 2023-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1347 participants
OBSERVATIONAL
2021-12-21
2023-07-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Strep A Fluorescent Immunoassay and Analyzer Field Study
NCT01441479
Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
NCT03422341
Detection of GABHS in Throat Gargle
NCT03231098
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
NCT03037957
Detection of Group A β-Hemolytic Streptococci in Oral Samples
NCT05223634
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. This study will take place in at least six sites in at least three different regions of the United States.
8. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Symptomatic Adult and Pediatric Subjects
Untrained lay user to collect throat swab specimen and perform investigational 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* pharyngeal pain \[with or without swallowing\],
* tonsillar swelling with exudates,
* pharyngeal erythema,
* tender cervical lymphadenopathy,
* fever.
2. Subjects who have not received antibiotic treatment within the past 14 days.
3. Subjects (or their parents/guardians) provide written informed consent/assent to participate in the study
Exclusion Criteria
5 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Curebase Inc.
INDUSTRY
Checkable Medical Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marla McIntyre
Role: STUDY_DIRECTOR
Checkable Medical
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Robertson Pediatrics
Beverly Hills, California, United States
Angel Kids Pediatrics
Jacksonville, Florida, United States
L&A Morales Health Care
Miami, Florida, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Waggoner Pediatrics
Clive, Iowa, United States
WellNow Urgent Care and Research
Kalamazoo, Michigan, United States
Axis Clinicals
Dilworth, Minnesota, United States
Infinitive Bio Research
Edison, New Jersey, United States
Twelve Corners Pediatrics
Rochester, New York, United States
AFC Urgent Care
The Bronx, New York, United States
Plains Clinical Research
Fargo, North Dakota, United States
Trinity Health
Minot, North Dakota, United States
WellNow Urgent Care and Research
Lorain, Ohio, United States
WellNow Urgent Care and Research
Milford, Ohio, United States
WellNow Urgent Care and Research
Troy, Ohio, United States
AFC Urgent Care
Easley, South Carolina, United States
Tribe Clinical Research
Greenville, South Carolina, United States
MDFirst
Lancaster, South Carolina, United States
Pediatric Associates
Houston, Texas, United States
Santa Clara Family Clinic
Houston, Texas, United States
Pediatric Center
Richmond, Texas, United States
North Houston Internal Medicine and Pediatric Clinic
Tomball, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CM-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.