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Characterization and Differential Diagnosis of Vertebral Osteomyelitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sang-Ho Choi, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01125839
First received: May 18, 2010
Last updated: February 24, 2014
Last verified: September 2013
  Purpose

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.


Condition
Vertebral Osteomyelitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Features, Microbiological-, Radiological Characteristics, and Differential Diagnosis of Vertebral Osteomyelitis

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Identification of etiology of vertebral osteomyelitis [ Time Frame: within 6 weeks after the diagnosis of vertebral osteomyelitis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unfavorable outcomes (death or permanent neurologic deficit) [ Time Frame: within 6 months after the diagnosis of vertebral osteomyelitis ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

CT guided biopsy specimen


Estimated Enrollment: 100
Study Start Date: May 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spondylitis
Patients who checked spine MRI for back pain

Detailed Description:

Besides description of characteristics of patients with vertebral osteomyelitis, we also will investigate the usefulness of 16S rRNA gene sequence analysis of biopsy specimen. MRI findings during the antibiotic treatment will be monitored and compared for the differential diagnosis of meningitis.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients that have MRI findings sugggestive of vertebral osteomyelitis

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients already treated more than 2 weeks for osteomyelitis in transferring hospital
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125839

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Sang-Ho Choi, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Sang-Ho Choi, Doctor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01125839     History of Changes
Other Study ID Numbers: AVOMS
Study First Received: May 18, 2010
Last Updated: February 24, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
osteomyelitis
16S rRNA
spine
Magnetic resonance imaging

Additional relevant MeSH terms:
Osteomyelitis
Bone Diseases
Bone Diseases, Infectious
Infection
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 19, 2014