Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-31 @ 12:08 AM
Study NCT ID:
NCT01734668
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sofia RSV 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': 2468}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-05', 'studyFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High level of sensitivity and specificity for performance vs. culture', 'timeFrame': 'Culture results within 48 hours of plating', 'description': 'Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Recruitment of RSV symptomatic pediatric subjects who are less than nineteen (19) years of age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female\n2. Children less than nineteen (19) years of age can participate (assuming appropriate consent is obtained).\n3. Must currently be exhibiting symptoms characteristic of respiratory syncytial virus (RSV) illness.\n4. Subjects must present with one or more of the following to be eligible for enrollment:\n\n * Fever, ≥ 37.8º C (100º F) at present or within past 24 hours\n * Moderate to severe runny nose\\*\n * Moderate to severe congestion\\*\n * Decreased appetite\n * Coughing\n * Sneezing\\*\n * Wheezing\n * Irritability\n * Decreased activity\n * Labored breathing\n\nExclusion Criteria:\n\n1. Subjects nineteen years of age or older.\n2. The parent or legal guardian is unable to understand and consent to participation.\n3. Current or prior treatment during this infection with anti-RSV Synagis®.'}, 'identificationModule': {'nctId': 'NCT01734668', 'briefTitle': 'Sofia RSV FIA Field Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quidel Corporation'}, 'officialTitle': 'Sofia RSV FIA Field Study', 'orgStudyIdInfo': {'id': 'CS-0143-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'In Vitro Diagnostic device to aid in diagnosis', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85042', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Best Medical Group', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'Santo Nino Medical Clinic', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '33435', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Genesis Community Health', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33435', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Gentle Medical Associates', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33483', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Pediatrics by the Sea', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33460', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Soma Pediatrics', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Adriana Castro', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Lanza Pediatrics', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33702', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Northeast Pediatrics', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Petersburg Pediatrics', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Teena Hughes, MD', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33406', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Soma Medical Center, PA Pediatric Site #3', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '33415', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Juan E. Batista, MD PA, Pediatric Site #2', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '07950', 'city': 'Morris Plains', 'state': 'New Jersey', 'country': 'United States', 'facility': 'FastER Urgent Care', 'geoPoint': {'lat': 40.82177, 'lon': -74.48099}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Twelve Corners Pediatrics', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '76513', 'city': 'Belton', 'state': 'Texas', 'country': 'United States', 'facility': 'Veritas, PA', 'geoPoint': {'lat': 31.05601, 'lon': -97.46445}}, {'zip': '22180', 'city': 'Vienna', 'state': 'Virginia', 'country': 'United States', 'facility': 'Advanced Pediatrics', 'geoPoint': {'lat': 38.90122, 'lon': -77.26526}}], 'overallOfficials': [{'name': 'John D Tamerius, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Quidel Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quidel Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}