Strep A FIA Field Study, Sofia

August 1, 2017 updated by: Quidel Corporation

Sofia Strep A FIA Field Study

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1708

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85042-6510
        • Best Medical Group, LLC
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Gentle Medical Associates
      • Delray Beach, Florida, United States, 33483
        • Pediatrics by the Sea
      • Tampa, Florida, United States, 33613
        • Teena Hughes, MD
    • New York
      • Rochester, New York, United States, 14618
        • Twelve Corners Pediatrics
    • Texas
      • Belton, Texas, United States, 76513
        • Veritas, PA
    • Virginia
      • Vienna, Virginia, United States, 22180
        • Advanced Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from the general population as they present to the clinical facility. Subjects must be exhibiting symptoms characteristic of pharyngitis, possibly GAS.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Symptomatic population for GAS
This study is a diagnostic study to aid in the detection of Strep throat. No intervention or medication is a part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Group A Streptococcus
Time Frame: Within 5 minutes
A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer
Within 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quidel Corporation

Investigators

  • Study Director: John D. Tamerius, PhD, Quidel Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CS-0142-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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