Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT04529733
Status:
UNKNOWN
Last Update Posted:
2020-08-28
First Post:
2020-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-24', 'studyFirstSubmitDate': '2020-08-14', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings, with corresponding procalcitonin measurements obtained in a ref or clinical laboratory using a comparative assay, with respect to the same EDTA plasma specimens', 'timeFrame': '1 day', 'description': 'Method comparison'}, {'measure': 'To establish the equivalence of IB10 sphingotest PCT+ measurements in EDTA whole blood and plasma specimens, as obtained in point-of-care settings as defined above', 'timeFrame': '1 day', 'description': 'Method comparison'}, {'measure': 'To establish equivalence of IB10 sphingotest PCT+ measurements in fresh EDTA plasma specimens and frozen EDTA plasma specimens', 'timeFrame': '24 hours', 'description': 'in vitro stability'}, {'measure': 'To establish the precision of IB10 sphingotest PCT+ measurements in point-of-care setting with respect to frozen EDTA plasma specimens', 'timeFrame': '1 day', 'description': 'Point of Care precision Testing'}, {'measure': 'To establish the in vitro stability of EDTA whole blood and plasma speciments with respect to procalitonin concentrations as measured by the of IB10 sphingotest PCT+ test.', 'timeFrame': '1 day', 'description': 'in vitro stability'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical laboratory using a comparative assay, with respect to the same subset of human EDTA plasma specimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is able and willing to provide written informed consent\n* Subject is 18 years of age or older\n* Subject is presenting with symptoms suggestive of bacterial infection\n* Subject is presenting with two or more of the following symptoms suggestive of systemic inflammatory response syndrome (SIRS):\n\n * Body temperature less than 36°C (96.8°F) or greater than 38°C (100.4°F);\n * Heart rate greater than 90 beats per minute;\n * Respiratory rate greater than 20 breaths per minute, or an arterial partial pressure of carbon dioxide (pCO2) less than 4.3 kPa (32 mmHg);\n * White blood cell count less than 4,000 cells/mm3 (4 x 109 cells/L) or greater than 12,000 cells/mm3 (12 x 109 cells/L);\n * A normal white blood cell count with the presence of greater\n * than 10% immature neutrophils.\n\nExclusion Criteria:\n\n* Subjects less than 18 years of age;\n* Subjects who do not present with a minimum of two symptoms suggestive of SIRS, as defined above\n* Subjects unable or unwilling to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT04529733', 'briefTitle': 'Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nexus DX'}, 'officialTitle': 'Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting', 'orgStudyIdInfo': {'id': 'B10-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IB10 sphingotest PCT+', 'type': 'DEVICE', 'description': 'Whole blood in EDTA for procalcitonin POC testing on IB10 sphingotest PCT+ device'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nexus DX', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}