Preview Rapid Strep A Test Method Comparison Study

NCT ID: NCT03907449

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-19

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Strep Throat

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptoms of Strep Throat

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

Preview Rapid Strep A test

Intervention Type DIAGNOSTIC_TEST

Rapid assay for the detection of type A streptococcal infection of the throat.

Interventions

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Preview Rapid Strep A test

Rapid assay for the detection of type A streptococcal infection of the throat.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Wondfo Biotech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Granato, PhD

Role: PRINCIPAL_INVESTIGATOR

UHSH Microbiology

Jagmohan Sidhu, MD

Role: PRINCIPAL_INVESTIGATOR

UHSH Microbiology

Locations

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UHSH Microbiology

Johnson City, New York, United States

Site Status

Summerwood Pediatrics

Liverpool, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MDC_2018_Wondfo

Identifier Type: -

Identifier Source: org_study_id

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