Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT02068469
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2014-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In Vitro Diagnostic Device for the Detection of Strep A
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Throat culture swab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 799}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2014-02-14', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture', 'timeFrame': 'Results based on samples collected at initial visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Streptococcal Sore Throat']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult and Pediatric primary care clinic, walk in clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are 3 years of age or older\n* Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including:\n\n * presence of sore throat, and at least one other symptom from the list below:\n * redness of the posterior pharyngeal wall\n * pharyngeal or tonsillar exudate\n * tonsillar swelling\n * tender cervical lymphadenopathy\n * fever, \\>38C at presentation or within the past 24 hours\n* Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian\n\nExclusion Criteria:\n\n* Subjects treated with antibiotics currently or within the previous 7 days.'}, 'identificationModule': {'nctId': 'NCT02068469', 'briefTitle': 'In Vitro Diagnostic Device for the Detection of Strep A', 'organization': {'class': 'INDUSTRY', 'fullName': 'IQuum, Inc.'}, 'officialTitle': 'Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A', 'orgStudyIdInfo': {'id': 'SASA 4.0'}}, 'contactsLocationsModule': {'locations': [{'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwich Pediatrics', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Twelve Corners Pediatrics', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Plano Pediatrics', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '22180', 'city': 'Vienna', 'state': 'Virginia', 'country': 'United States', 'facility': 'Advanced Pediatrics', 'geoPoint': {'lat': 38.90122, 'lon': -77.26526}}], 'overallOfficials': [{'name': 'Lingjun Chen, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IQuum COO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IQuum, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Roche Molecular Systems, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}