Strep A Fluorescent Immunoassay and Analyzer Field Study

Strep Throat Clinical Trial

Official title:

Strep A Fluorescent Immunoassay and Analyzer Field Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441479
• Other study ID #: CS-0142-01
• Status: Completed
• Phase: N/A
• First received: September 23, 2011
• Last updated: February 5, 2013
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: December 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 Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1282
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects three (3) years of age or older

Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis

• Extreme sore throat

• Redness of the posterior pharyngeal wall

• Difficulty Swallowing

• Fever, >38.7C (100F) at presentation or within past 24 hours

• Pharyngeal exudate

• Tender cervical lymphadenopathy

• Absence of cough or other upper respiratory symptoms

Exclusion Criteria:

• Subjects currently under treatment with antibiotics 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

• Strep Throat

Intervention

Device:
• In Vitro Diagnostic Device aid in diagnosing

Locations

Country	Name	City	State
United States	La Costa Pediatrics	Carlsbad	California
United States	FastER Urgent Care	Morris Plains	New Jersey
United States	Best Medical Group	Phoenix	Arizona
United States	Twelve Corners Pediatrics	Rochester	New York
United States	La Jolla Pediatrics	San Diego	California
United States	Teena Hughes	Tampa	Florida
United States	Advanced Pediatrics	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Quidel Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Streptococcus Group B identification	The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done.	Immediate	Yes