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Sofia Strep A FIA Field Study

NCT ID: NCT01494792

Last Updated: 2012-10-10

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

TERMINATED

Total Enrollment

2090 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.

Detailed Description

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Conditions

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Group A Streptococcus Strep Throat

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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In Vitro Diagnositc aid for diagnosis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Presence of sore throat
* Redness of the posterior pharyngeal wall
* Tonsillar exudate
* Tonsillar swelling
* Tender anterior cervical adenopathy
* Fever, \> 38º C (100.4ºF) at presentation or within past 24 hours

Other symptoms that may be present, in addition to above symptoms for GAS:

* Rash, typical of scarlet fever
* Abnormal tympanic membranes
* Palatal petechiae

Exclusion Criteria

* Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study.
* At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quidel Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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La Costa Pediatrics

Carlsbad, California, United States

Site Status

Santo Nino Medical Clinic

Panorama City, California, United States

Site Status

La Jolla Pediatrics

San Diego, California, United States

Site Status

Teena Hughes, MD

Tampa, Florida, United States

Site Status

Children's Memorial Hospital

Chicago, Illinois, United States

Site Status

Twelve Corners Pediatrics

Rochester, New York, United States

Site Status

Montrose Family Practice

Akron, Ohio, United States

Site Status

Advanced Pediatrics

Vienna, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CS-0142-02

Identifier Type: -

Identifier Source: org_study_id