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Strep A FIA Field Study, Sofia

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ClinicalTrials.gov Identifier: NCT02153008
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Quidel Corporation

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

Condition or disease
Group A Streptococcus

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Study Type : Observational
Actual Enrollment : 1708 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Sofia Strep A FIA Field Study
Actual Study Start Date : April 2014
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : July 1, 2016

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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.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153008


Locations
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United States, Arizona
Best Medical Group, LLC
Phoenix, Arizona, United States, 85042-6510
United States, Florida
Gentle Medical Associates
Boynton Beach, Florida, United States, 33435
Pediatrics by the Sea
Delray Beach, Florida, United States, 33483
Teena Hughes, MD
Tampa, Florida, United States, 33613
United States, New York
Twelve Corners Pediatrics
Rochester, New York, United States, 14618
United States, Texas
Veritas, PA
Belton, Texas, United States, 76513
United States, Virginia
Advanced Pediatrics
Vienna, Virginia, United States, 22180
Sponsors and Collaborators
Quidel Corporation
Investigators
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Study Director: John D. Tamerius, PhD Quidel Corporation

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Responsible Party: Quidel Corporation
ClinicalTrials.gov Identifier: NCT02153008     History of Changes
Other Study ID Numbers: CS-0142-07
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Keywords provided by Quidel Corporation:
Strep throat