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Sofia Strep A FIA Field Study

This study has been terminated.
(Performance did not meet sponsor requirements.)
Sponsor:
Information provided by (Responsible Party):
Quidel Corporation
ClinicalTrials.gov Identifier:
NCT01494792
First received: December 15, 2011
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.


Condition Intervention
Group A Streptococcus
Strep Throat
 Device: In Vitro Diagnositc aid for diagnosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Sofia Strep A FIA Field Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Quidel Corporation:

Enrollment: 2090
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects must be three (3) years of age or older and exhibiting symptoms characteristics of pharyngitis, possibly Group A Streptococcus.

Criteria

Inclusion Criteria:

  • Presence of sore throat
  • Redness of the posterior pharyngeal wall
  • Tonsillar exudate
  • Tonsillar swelling
  • Tender anterior cervical adenopathy
  • Fever, > 38º C (100.4ºF) at presentation or within past 24 hours

Other symptoms that may be present, in addition to above symptoms for GAS:

  • Rash, typical of scarlet fever
  • Abnormal tympanic membranes
  • Palatal petechiae

Exclusion Criteria:

  • Subjects treated with antibiotics currently or within the previous week (7 days) 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494792

Locations
United States, California
La Costa Pediatrics
Carlsbad, California, United States, 92009
Santo Nino Medical Clinic
Panorama City, California, United States, 91402
La Jolla Pediatrics
San Diego, California, United States, 92121
United States, Florida
Teena Hughes, MD
Tampa, Florida, United States, 33613
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614-3394
United States, New York
Twelve Corners Pediatrics
Rochester, New York, United States, 14618
United States, Ohio
Montrose Family Practice
Akron, Ohio, United States, 44333
United States, Virginia
Advanced Pediatrics
Vienna, Virginia, United States, 22180
Sponsors and Collaborators
Quidel Corporation
  More Information

No publications provided

Responsible Party: Quidel Corporation
ClinicalTrials.gov Identifier: NCT01494792     History of Changes
Other Study ID Numbers: CS-0142-02
Study First Received: December 15, 2011
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013