Strep A FIA Field Study, Sofia

Group A Streptococcus Clinical Trial

Official title:

Sofia Strep A FIA Field Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153008
• Other study ID #: CS-0142-07
• Status: Completed
• Phase: N/A
• First received: May 29, 2014
• Last updated: August 1, 2017
• Start date: April 2014
• Est. completion date: July 1, 2016

Study information

• Verified date: August 2017
• Source: Quidel Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1708
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Group A Streptococcus

Locations

Country	Name	City	State
United States	Veritas, PA	Belton	Texas
United States	Gentle Medical Associates	Boynton Beach	Florida
United States	Pediatrics by the Sea	Delray Beach	Florida
United States	Best Medical Group, LLC	Phoenix	Arizona
United States	Twelve Corners Pediatrics	Rochester	New York
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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Group A Streptococcus	A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer	Within 5 minutes