Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT06654895
Status:
RECRUITING
Last Update Posted:
2024-12-10
First Post:
2024-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-10-15', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days', 'timeFrame': 'Within 28 days after inclusion', 'description': 'Participants will be followed up for 28 days for all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'In-hospital mortality up to 28 days', 'timeFrame': 'Within 28 days after inclusion', 'description': 'Participants will be followed up for 28 days for in-hospital mortality'}, {'measure': 'All-cause mortality up to 7 days', 'timeFrame': 'Within 7 days after inclusion', 'description': 'Participants will be followed up for 7 days for all-cause mortality'}, {'measure': 'Sequential Organ Failure Assessment (SOFA) score', 'timeFrame': 'Within 28 days after inclusion', 'description': 'SOFA score has a range from 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s).'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Within 28 days after inclusion', 'description': 'Participants will be followed up for hospital length of stay for up to 28 days'}, {'measure': 'ICU length of stay', 'timeFrame': 'Within 28 days after inclusion', 'description': 'Participants will be followed up for ICU length of stay for up to 28 days'}, {'measure': 'Vasopressor utilization', 'timeFrame': 'Within 28 days after inclusion', 'description': 'Participants will be followed up for use of Vasopressors for up to 28 days'}, {'measure': 'Progression to septic shock', 'timeFrame': 'Within 28 days after inclusion', 'description': 'Participants will be followed up for progression to septic shock for up to 28 days'}, {'measure': '28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock', 'timeFrame': 'Within 28 days after inclusion', 'description': 'Participants will be followed up for 28 days for all-cause mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interleukin-6', 'IL-6', 'Risk Stratification', 'Infections', 'Toxima', 'Systemic Inflammatory Response Syndrome', 'Inflammation', 'Pathologic Processes', 'Sepsis', 'Septic Shock', 'Shock'], 'conditions': ['Sepsis, Septic Shock']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed with sepsis or septic shock, in accordance with the sepsis-3 criteria, admitted or intended to be admitted to the ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥22 years of age)\n* Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.\n\n * Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2\n * Septic shock: sepsis requiring vasopressors and serum lactate levels \\>2 mmol/L (18 mg/dL)\n* Admitted or intended to be admitted to the ICU\n* At least 3 mL plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock.\n\nExclusion Criteria:\n\n* Prisoners or imprisonment at time of enrollment\n* Prior enrollment into this study\n* Informed consent as approved by IRB is unable to be obtained.'}, 'identificationModule': {'nctId': 'NCT06654895', 'acronym': 'SYMON II', 'briefTitle': 'Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bluejay Diagnostics, Inc.'}, 'officialTitle': 'Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study', 'orgStudyIdInfo': {'id': 'CES-0008'}}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Office of Research College of Medicine', 'role': 'CONTACT', 'email': 'com-research@ufl.edu', 'phone': '352-273-5946'}], 'facility': 'University of Florida College of Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Affairs', 'role': 'CONTACT'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Translation Science Institute', 'role': 'CONTACT', 'email': 'ctsi@wakehealth.edu', 'phone': '336-716-1195'}], 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'VUMC Office of Research', 'role': 'CONTACT', 'email': 'sponsoredprograms@vumc.org', 'phone': '615-322-5000'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84111', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Affairs', 'role': 'CONTACT'}], 'facility': 'Intermountain Health', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Clinical Affairs', 'role': 'CONTACT', 'email': 'clinical@bluejaydx.com', 'phone': '844-327-7078'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bluejay Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}