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NCT Number: NCT05464251

Prospective Analysis of Spinal Epidural Abscess

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.

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Key information

Conditions

Spinal Epidural Abscess Abscess Central Nervous System Diseases Central Nervous System Infections Epidural Abscess Infections Nervous System Diseases Perimeningeal Infections Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patient with ICD codes for pyogenic vertebral osteomyelitis, discitis, and spinal epidural abscess will be reviewed for inclusion.

Exclusion criteria

  • Patients unwilling or unable to attend follow up appointments.

Treatment and study plan

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.

Primary outcomes

  1. Correlation between employment status and infection reoccurrence.

    Time frame: 1 year

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

  2. Correlation between income and infection reoccurrence.

    Time frame: 1 year

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

  3. Correlation between insurer and infection reoccurrence.

    Time frame: 1 year

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

  4. Correlation between living situation and infection reoccurrence.

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Francis Farhadi, MD, PhD

CONTACT

[email protected]

859-562-0247

Harshit Arora, PhD

CONTACT

[email protected]

859-323-4533

Sponsors and collaborators

Lead sponsor

Francis Farhadi

Other

Registry information

Official study title

Prospective Analysis of Spinal Epidural Abscess Associated Outcomes at the University of Kentucky

Acronym: SEA

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2022
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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