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NCT03907449 Clinical Trial

Preview Rapid Strep A Test Method Comparison Study

Strep Throat Clinical Trial

Official title:
Preview Rapid Strep A Test Method Comparison Study

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT03907449
Other study ID # MDC_2018_Wondfo
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date March 19, 2019
Est. completion date May 2020

Study information
Verified date July 2019
Source Guangzhou Wondfo Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.

Recruitment information / eligibility
Status Suspended
Enrollment 320
Est. completion date May 2020
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility Inclusion Criteria:

- Any patient presenting with symptoms of pharyngitis

- Fever

- Sore throat

- Swollen lymph nodes in neck

- Redness of throat/tonsils

- White/yellow patches on tonsils

- Not currently on antibiotics

- =3 years or older

- Ability to read, understand and sign a consent form, in English, or for parent(s) to sign an assent form providing permission to include children under the age of 18.

Exclusion Criteria:

- Currently taking antibiotics

- Previously enrolled in this study

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Preview Rapid Strep A test
Rapid assay for the detection of type A streptococcal infection of the throat.

Locations
Country Name City State
United States UHSH Microbiology Johnson City New York
United States Summerwood Pediatrics Liverpool New York

Sponsors (1)
Lead Sponsor Collaborator
Guangzhou Wondfo Biotech Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of Preview Strep A Rapid Test Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A 3 months
See also
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Enrolling by invitation NCT04084977 - Dopaminergic Receptors in Sydenham's Chorea
Recruiting NCT01491776 - Evaluation of the IND One Step Strep A Rapid Test vs. Culture N/A