Spinal Epidural AbscessSEANCT05464251
Prospective Analysis of Spinal Epidural Abscess
An observational study of Spinal Epidural Abscess, run by Francis Farhadi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Epidural Abscess
- What is being tested?
- Prospective chart review of subjects diagnosed with spinal epidural abscess
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patient with ICD codes for pyogenic vertebral osteomyelitis, discitis, and spinal epidural abscess will be reviewed for inclusion.
Who cannot join
- Patients unwilling or unable to attend follow up appointments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Francis Farhadi, MD, PhD, 859-562-0247, francis.farhadi@uky.edu
Harshit Arora, PhD, 859-323-4533, harshit.arora@uky.edu
About this study
Official title: Prospective Analysis of Spinal Epidural Abscess Associated Outcomes at the University of Kentucky
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
- Being tested
- Prospective chart review of subjects diagnosed with spinal epidural abscess
- Medical subject headings
- Epidural Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective chart review of subjects diagnosed with spinal epidural abscessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with spinal epidural abscess with a history of drug abuse | Not described Receives: Other: Prospective chart review of subjects diagnosed with spinal epidural abscess | |
| Subjects with spinal epidural abscess with no history of drug abuse | Not described Receives: Other: Prospective chart review of subjects diagnosed with spinal epidural abscess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between employment status and infection reoccurrence.
Determine the statistical correlation between employment status and infection reoccurrence within 1 year of diagnosis.
Measured: 1 year
Correlation between income and infection reoccurrence.
Determine the statistical correlation between income and infection reoccurrence within 1 year of diagnosis.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start12 Jul 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Epidural AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francis Farhadi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francis Farhadi, University of Kentucky
- Investigators
- Francis Farhadi, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464251
- Sponsor's protocol ID
- 78749
- Acronym
- SEA
- Status last verified
- Feb 2026
- First submitted
- 28 Jun 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Spinal Epidural Abscess Associated Outcomes at the University of Kentucky
- ClinicalTrials.gov ID
- NCT05464251
- Acronym / sponsor ID
- SEA / 78749
- Conditions
- Spinal Epidural Abscess
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Francis FarhadiUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patient with ICD codes for pyogenic vertebral osteomyelitis, discitis, and spinal epidural abscess will be reviewed for inclusion.
Key exclusion criteria (1 listed)
- Patients unwilling or unable to attend follow up appointments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective chart review of subjects diagnosed with spinal epidural abscessCollection 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. | Other | Subjects with spinal epidural abscess with a history of drug abuse, Subjects with spinal epidural abscess with no history of drug abuse |
Primary outcome
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.
Correlation between income and infection reoccurrence.
Time frame: 1 year
Determine the statistical correlation between income and infection reoccurrence within 1 year of diagnosis.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francis Farhadi, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Epidural Abscess, run by Francis Farhadi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francis Farhadi, MD, PhD (859-562-0247, francis.farhadi@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between employment status and infection reoccurrence. (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.