Prospective Analysis of Spinal Epidural Abscess

NCT05464251 | Recruiting

• 1 other identifier: 78749
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Epidural Abscess

Outcome Measures

Primary Outcomes (4)

• Correlation between employment status and infection reoccurrence.

  Determine the statistical correlation between employment status and infection reoccurrence within 1 year of diagnosis.

  1 year

• Correlation between income and infection reoccurrence.

  Determine the statistical correlation between income and infection reoccurrence within 1 year of diagnosis.

  1 year

• Correlation between insurer and infection reoccurrence.

  Determine the statistical correlation between insurer (private, Medicare/Medicade and uninsured) and infection reoccurrence within 1 year of diagnosis.

  1 year

• Correlation between living situation and infection reoccurrence.

  Determine the statistical correlation between living situation (owns, rents, or homeless) and infection reoccurrence within 1 year of diagnosis.

  1 year

Study Arms (2)

Subjects with spinal epidural abscess with a history of drug abuse

Other: Prospective chart review of subjects diagnosed with spinal epidural abscess

Subjects with spinal epidural abscess with no history of drug abuse

Other: Prospective chart review of subjects diagnosed with spinal epidural abscess

Interventions

Prospective chart review of subjects diagnosed with spinal epidural abscess OTHER

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.

Subjects with spinal epidural abscess with a history of drug abuse; Subjects with spinal epidural abscess with no history of drug abuse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may not qualify if:

• Patients unwilling or unable to attend follow up appointments.

Sponsors & Collaborators

• Francis Farhadi: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Epidural Abscess

Condition Hierarchy (Ancestors)

Perimeningeal Infections; Central Nervous System Infections; Infections; Abscess; Suppuration; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Francis Farhadi, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis Farhadi, MD, PhD

CONTACT

859-562-0247; francis.farhadi@uky.edu

Harshit Arora, PhD

CONTACT

859-323-4533; harshit.arora@uky.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 19, 2022
• Study Start: July 12, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)