Clinical trial NCT05107362: Clinical Performance of the Checkable Medical At-Home Strep A Test
Official title: Clinical Performance of the Checkable Medical At-Home Strep A Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Streptococcus Pyogenes Infection
Pharyngitis
Respiratory Tract Infections
Keywords: In vitro diagnostic
Lead sponsor: Checkable Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Curebase Inc.
First posted: 2021-11-04
Enrollment: 1347
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
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:

1. Lay users who are accompanying patients are unwilling/unable to collect throat swab sample from a child or adult.

Primary outcomes:
measure: Clinical Sensitivity and Clinical Specificity
timeFrame: 1 day
Secondary outcomes:
measure: Negative Predictive Value
timeFrame: 1 day
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Robertson Pediatrics
state: California
city: Jacksonville
country: United States
facility: Angel Kids Pediatrics
state: Florida
city: Miami
country: United States
facility: L&A Morales Health Care
state: Florida
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Clive
country: United States
facility: Waggoner Pediatrics
state: Iowa
city: Kalamazoo
country: United States
facility: WellNow Urgent Care and Research
state: Michigan
city: Dilworth
country: United States
facility: Axis Clinicals
state: Minnesota
city: Edison
country: United States
facility: Infinitive Bio Research
state: New Jersey
city: Bronx
country: United States
facility: AFC Urgent Care
state: New York
city: Rochester
country: United States
facility: Twelve Corners Pediatrics
state: New York
city: Fargo
country: United States
facility: Plains Clinical Research
state: North Dakota
city: Minot
country: United States
facility: Trinity Health
state: North Dakota
city: Lorain
country: United States
facility: WellNow Urgent Care and Research
state: Ohio
city: Milford
country: United States
facility: WellNow Urgent Care and Research
state: Ohio
city: Troy
country: United States
facility: WellNow Urgent Care and Research
state: Ohio
city: Easley
country: United States
facility: AFC Urgent Care
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research
state: South Carolina
city: Lancaster
country: United States
facility: MDFirst
state: South Carolina
city: Houston
country: United States
facility: Pediatric Associates
state: Texas
city: Houston
country: United States
facility: Santa Clara Family Clinic
state: Texas
city: Richmond
country: United States
facility: Pediatric Center
state: Texas
city: Tomball
country: United States
facility: North Houston Internal Medicine and Pediatric Clinic
state: Texas
Study officials:
affiliation: Checkable Medical
name: Marla McIntyre
role: STUDY_DIRECTOR
References: