Sofia Strep A FIA Field Study

Strep Throat Clinical Trial

Official title:

Sofia Strep A FIA Field Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01494792
• Other study ID #: CS-0142-02
• Status: Terminated
• Phase: N/A
• First received: December 15, 2011
• Last updated: October 5, 2012
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Quidel Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2090
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Group A Streptococcus
• Strep Throat

Intervention

Device:
• In Vitro Diagnositc aid for diagnosis

Locations

Country	Name	City	State
United States	Montrose Family Practice	Akron	Ohio
United States	La Costa Pediatrics	Carlsbad	California
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Santo Nino Medical Clinic	Panorama City	California
United States	Twelve Corners Pediatrics	Rochester	New York
United States	La Jolla Pediatrics	San Diego	California
United States	Teena Hughes, MD	Tampa	Florida
United States	Advanced Pediatrics	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Quidel Corporation

Country where clinical trial is conducted

United States,