Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT05464251
Status:
RECRUITING
Last Update Posted:
2025-01-16
First Post:
2022-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Analysis of Spinal Epidural Abscess
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020802', 'term': 'Epidural Abscess'}], 'ancestors': [{'id': 'D020819', 'term': 'Perimeningeal Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between employment status and infection reoccurrence.', 'timeFrame': '1 year', 'description': 'Determine the statistical correlation between employment status and infection reoccurrence within 1 year of diagnosis.'}, {'measure': 'Correlation between income and infection reoccurrence.', 'timeFrame': '1 year', 'description': 'Determine the statistical correlation between income and infection reoccurrence within 1 year of diagnosis.'}, {'measure': 'Correlation between insurer and infection reoccurrence.', 'timeFrame': '1 year', 'description': 'Determine the statistical correlation between insurer (private, Medicare/Medicade and uninsured) and infection reoccurrence within 1 year of diagnosis.'}, {'measure': 'Correlation between living situation and infection reoccurrence.', 'timeFrame': '1 year', 'description': 'Determine the statistical correlation between living situation (owns, rents, or homeless) and infection reoccurrence within 1 year of diagnosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Epidural Abscess']}, 'descriptionModule': {'briefSummary': "This is a prospective study involving all patients treated at the University of Kentucky for spinal epidural abscess over a 2-year period. Based on ongoing referrals of patients with SEA, we expect that 200 patients will be enrolled during this time window. We propose to study all available clinical, pathological, radiological, and socioeconomic data of patients diagnosed with a spinal infection with or without a history of drug abuse over this study period. All patients' charts will be prospectively reviewed starting at the time of presentation for a period of 1 year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include all patients, over the age of 18, who will undergo treatment for spinal epidural abscess infections at the University of Kentucky during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patient with ICD codes for pyogenic vertebral osteomyelitis, discitis, and spinal epidural abscess will be reviewed for inclusion.\n\nExclusion Criteria:\n\n* Patients unwilling or unable to attend follow up appointments.'}, 'identificationModule': {'nctId': 'NCT05464251', 'acronym': 'SEA', 'briefTitle': 'Prospective Analysis of Spinal Epidural Abscess', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Prospective Analysis of Spinal Epidural Abscess Associated Outcomes at the University of Kentucky', 'orgStudyIdInfo': {'id': '78749'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with spinal epidural abscess with a history of drug abuse', 'interventionNames': ['Other: Prospective chart review of subjects diagnosed with spinal epidural abscess']}, {'label': 'Subjects with spinal epidural abscess with no history of drug abuse', 'interventionNames': ['Other: Prospective chart review of subjects diagnosed with spinal epidural abscess']}], 'interventions': [{'name': 'Prospective chart review of subjects diagnosed with spinal epidural abscess', 'type': 'OTHER', 'description': 'Collection and assessment of available clinical, pathological, radiological, and socioeconomic data on subjects presenting with spinal epidural abscess. Standard of care treatment and outcomes for each group will be analyzed.', 'armGroupLabels': ['Subjects with spinal epidural abscess with a history of drug abuse', 'Subjects with spinal epidural abscess with no history of drug abuse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Francis Farhadi, MD, PhD', 'role': 'CONTACT', 'email': 'francis.farhadi@uky.edu', 'phone': '859-562-0247'}, {'name': 'Jaimie Hixson, BS', 'role': 'CONTACT', 'email': 'jlhend3@uky.edu', 'phone': '859-323-1908'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Francis Farhadi, MD, PhD', 'role': 'CONTACT', 'email': 'francis.farhadi@uky.edu', 'phone': '859-562-0247'}, {'name': 'Jaimie Hixson', 'role': 'CONTACT', 'email': 'henderson.jaimie@gmail.com', 'phone': '8593231908'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kentucky', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Francis Farhadi', 'investigatorAffiliation': 'University of Kentucky'}}}}