Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-02-22 @ 4:11 AM
Study NCT ID:
NCT02087761
Status:
UNKNOWN
Last Update Posted:
2016-03-02
First Post:
2014-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasal-pharyngeal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2014-03-12', 'studyFirstSubmitQcDate': '2014-03-12', 'lastUpdatePostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).', 'timeFrame': 'Within the first year of sample collection', 'description': 'Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Flu assay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ARIES Flu'], 'conditions': ['Respiratory Tract Infection', 'Bronchitis', 'Pneumonia']}, 'descriptionModule': {'briefSummary': 'The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens.\n\nThe objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.', 'detailedDescription': 'The ARIES Flu Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.\n\nThe objective is to establish the diagnostic accuracy of ARIES Flu Assay through a multi-site, method comparison on prospectively collected, left-over, and de-identified, nasopharyngeal swab specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All comers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The specimen is from a patient suspected of having respiratory tract infection for whom a requisition has been made for viral testing\n* The specimen is from a male of female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.\n* The specimen is a nasopharyngeal swab\n\nExclusion Criteria:\n\n* The specimen is NOT a nasopharyngeal swab\n* The specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.'}, 'identificationModule': {'nctId': 'NCT02087761', 'briefTitle': 'A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luminex Molecular Diagnostics'}, 'officialTitle': 'A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients', 'orgStudyIdInfo': {'id': 'LMA-FLU-01-CS-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '63119', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore-LIJ Health System Laboratories', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Health', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}], 'overallOfficials': [{'name': 'David Himsworth', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Luminex Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luminex Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}