NCT01125839

Brief Summary

Vertebral osteomyelitis is a uncommon disease that can lead to neurologic deficits if not diagnosed in time. The etiologies of vertebral osteomyelitis include pyogenic bacteria, M. tuberculosis, Brucella species, and fungus. The aim of this study is to describe the clinical features and microbiological/radiological characteristics of patients with vertebral osteomyelitis, and investigate the useful tips for the differential diagnosis of vertebral osteomyelitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 25, 2014

Status Verified

September 1, 2013

Enrollment Period

3.6 years

First QC Date

May 18, 2010

Last Update Submit

February 24, 2014

Conditions

Vertebral Osteomyelitis

Keywords

osteomyelitis16S rRNAspineMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Identification of etiology of vertebral osteomyelitis

    within 6 weeks after the diagnosis of vertebral osteomyelitis

Secondary Outcomes (1)

  • Unfavorable outcomes (death or permanent neurologic deficit)

    within 6 months after the diagnosis of vertebral osteomyelitis

Study Arms (1)

Spondylitis

Patients who checked spine MRI for back pain

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients that have MRI findings sugggestive of vertebral osteomyelitis

You may qualify if:

  • Symptoms or signs consistent with spinal column infection
  • MRI findings suggestive of infection
  • Antibiotic treatment for vertebral myelitis

You may not qualify if:

  • Patients already treated more than 2 weeks for osteomyelitis in transferring hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

CT guided biopsy specimen

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Sang-Ho Choi, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 19, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 25, 2014

Record last verified: 2013-09

Locations

KR(1)