Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-26 @ 9:24 AM
Study NCT ID:
NCT01309568
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
2011-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Leftover nasal mucus placed in viral transport media will be retained after culture for possible RT-PCR.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-10', 'studyFirstSubmitDate': '2011-03-03', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of infection with influenza', 'timeFrame': '15 minutes', 'description': 'Accurate diagnosis of infection with influenza A or influenza B confirmed by culture'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.', 'detailedDescription': 'A sufficient number of subjects will be enrolled to achieve a required minimum of cell culture-positive specimens for each sample type, nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash.\n\n* The 510(k) study will include combined results from all sites and require the following for all three sample types: a minimum of 50 fresh positive results for influenza A, and 30 fresh positive results for influenza B.\n* The CLIA Waiver submission will include combined results from all sites for a total of 120 positive specimens for both influenza A and influenza B. The nasal swab will be the primary sample type planned for the CLIA Waiver submission. However, depending upon the prevalence of influenza, nasopharyngeal swab and/or nasopharyngeal aspirate/wash may also be submitted for CLIA Waiver.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects current exhibiting influenza like illness.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female, of all ages (assuming appropriate consent is obtained).\n2. Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI).\n\nFor example:\n\n1. Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days.\n2. Nasal congestion\n3. Rhinorrhea\n4. Sore throat\n5. Cough\n6. Headache\n7. Myalgia\n8. Malaise\n\nExclusion Criteria:\n\n1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.\n2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.\n3. Unable to understand and consent to participation; for minors this includes parent or legal guardian.'}, 'identificationModule': {'nctId': 'NCT01309568', 'briefTitle': '"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quidel Corporation'}, 'officialTitle': '"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"', 'orgStudyIdInfo': {'id': 'CS-0138-01-A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Investigational testing', 'description': 'Pending the outcome of culture, the subject may be treated with an approved antiviral medication at the doctors discretion.'}]}, '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': '80234', 'city': 'Northglenn', 'state': 'Colorado', 'country': 'United States', 'facility': 'Complete Family Care', 'geoPoint': {'lat': 39.88554, 'lon': -104.9872}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Adriana Castro, MD', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Teena Hughes, MD', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60564', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'DuPage Family Medicine', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '41042', 'city': 'Florence', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Paul Janson, MD', 'geoPoint': {'lat': 38.99895, 'lon': -84.62661}}, {'zip': '40353', 'city': 'Mount Sterling', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Paul McLaughlin, MD', 'geoPoint': {'lat': 38.05647, 'lon': -83.94326}}, {'zip': '21040', 'city': 'Edgewood', 'state': 'Maryland', 'country': 'United States', 'facility': 'Kamakshi Neelkantan, MD', 'geoPoint': {'lat': 39.41872, 'lon': -76.2944}}, {'zip': '64155', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Priority Care Pediatrics', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '11691', 'city': 'Far Rockaway', 'state': 'New York', 'country': 'United States', 'facility': 'Robert Farron, DO', 'geoPoint': {'lat': 40.60538, 'lon': -73.75513}}, {'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': '19401', 'city': 'Norristown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Norristown Family Physicians', 'geoPoint': {'lat': 40.1215, 'lon': -75.3399}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "Dell's Children's Medical Center", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'John D Tamerius, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Quidel Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quidel Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'John D. Tamerius, PhD, Sr. V.P. Clinical/Regulatory', 'oldOrganization': 'Quidel Corporation'}}}}