Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 10:57 PM
Study NCT ID:
NCT03037957
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 704}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance (sensitivity/specificity) for Group A Strep Assay', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharyngitis Bacterial']}, 'descriptionModule': {'briefSummary': 'A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with signs and symptoms of pharyngitis for which their doctors ordered a Group A Strep test.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient and/or patient's legal guardian is willing and able to give informed consent and/or assent for extra research sample.\n* The subject's specimen is a throat swab in Liquid Amies based transport medium.\n* The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinical or resident of a long term care facility.\n* The specimen is from a patient for whom a requisition has been made for Group A Strep testing\n* The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis consistent with Group A Strep infection.\n* The specimen was received in good condition (no leakage or drying of the specimen).\n* The specimen volume is ≥ 850 µL.\n\nExclusion Criteria:\n\n* The specimen is from a patient who did not provide informed consent/assent.\n* The specimen is not a throat swab collected in Liquid Amies based transport medium.\n* The specimen is from a patient who is undergoing antibiotic treatment.\n* The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 9 below.\n* The specimen volume is \\< 850 µL."}, 'identificationModule': {'nctId': 'NCT03037957', 'briefTitle': 'A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luminex Molecular Diagnostics'}, 'officialTitle': 'A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients', 'orgStudyIdInfo': {'id': 'LMA-GAS-01-CS-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A Strep Assay', 'interventionNames': ['Device: ARIES Group A Strep Assay']}], 'interventions': [{'name': 'ARIES Group A Strep Assay', 'type': 'DEVICE', 'armGroupLabels': ['Group A Strep Assay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Sacred Heart Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '54449', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '22180', 'city': 'Vienna', 'state': 'Virginia', 'country': 'United States', 'facility': 'Advanced Pediatrics Research', 'geoPoint': {'lat': 38.90122, 'lon': -77.26526}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Labs', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'Ronald Dunn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Luminex Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luminex Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}