Strep A FIA Field Study, Sofia

Completed

• Conditions: Group A Streptococcus

• Registration Number: NCT02153008
• Lead Sponsor: Quidel Corporation

Brief Summary

To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-06-02
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1708

Inclusion Criteria

1. Male and Female, 3 years of age or older
2. Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study.

For example:

1. Acute onset of sore throat

2. Redness of the posterior pharyngeal wall

3. Difficulty/pain on swallowing

4. Fever, > 37.8º C (100ºF) at presentation or within past 24 hours

5. Pharyngeal exudate

6. Tender cervical lymphadenopathy

7. Absence of cough, runny nose or other upper respiratory symptoms.*

8. Other, symptoms specific to Strep A not listed above.

   • Must include at least one additional symptom from a-f and cannot be the only criteria used to meet inclusion for enrollment in the study.

Exclusion Criteria

1. Subjects currently under treatment with antibiotics are not to be included in this study.
2. At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of Group A Streptococcus	Within 5 minutes	A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer

Trial Locations

Locations (7)

Best Medical Group, LLC; 🇺🇸 Phoenix, Arizona, United States

Gentle Medical Associates; 🇺🇸 Boynton Beach, Florida, United States

Pediatrics by the Sea; 🇺🇸 Delray Beach, Florida, United States

Teena Hughes, MD; 🇺🇸 Tampa, Florida, United States

Twelve Corners Pediatrics; 🇺🇸 Rochester, New York, United States

Veritas, PA; 🇺🇸 Belton, Texas, United States

Advanced Pediatrics; 🇺🇸 Vienna, Virginia, United States