Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 10:08 PM
Study NCT ID:
NCT01494792
Status:
TERMINATED
Last Update Posted:
2012-10-10
First Post:
2011-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sofia Strep A FIA Field Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2090}}, 'statusModule': {'whyStopped': 'Performance did not meet sponsor requirements.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-05', 'studyFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2011-12-16', 'lastUpdatePostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Group A Streptococcus', 'Strep Throat']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects must be three (3) years of age or older and exhibiting symptoms characteristics of pharyngitis, possibly Group A Streptococcus.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of sore throat\n* Redness of the posterior pharyngeal wall\n* Tonsillar exudate\n* Tonsillar swelling\n* Tender anterior cervical adenopathy\n* Fever, \\> 38º C (100.4ºF) at presentation or within past 24 hours\n\nOther symptoms that may be present, in addition to above symptoms for GAS:\n\n* Rash, typical of scarlet fever\n* Abnormal tympanic membranes\n* Palatal petechiae\n\nExclusion Criteria:\n\n* Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study.\n* At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.'}, 'identificationModule': {'nctId': 'NCT01494792', 'briefTitle': 'Sofia Strep A FIA Field Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quidel Corporation'}, 'officialTitle': 'Sofia Strep A FIA Field Study', 'orgStudyIdInfo': {'id': 'CS-0142-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'In Vitro Diagnositc aid for diagnosis', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92009', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'La Costa Pediatrics', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'Santo Nino Medical Clinic', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'La Jolla Pediatrics', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Teena Hughes, MD', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60614-3394', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Twelve Corners Pediatrics', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44333', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Montrose Family Practice', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '22180', 'city': 'Vienna', 'state': 'Virginia', 'country': 'United States', 'facility': 'Advanced Pediatrics', 'geoPoint': {'lat': 38.90122, 'lon': -77.26526}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quidel Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}