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Characterization and Differential Diagnosis of Vertebral Osteomyelitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01125839
First Posted: May 19, 2010
Last Update Posted: February 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sang-Ho Choi, Asan Medical Center
  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 Sang-Ho Choi, Asan Medical Center:

Primary Outcome Measures:
  • Identification of etiology of vertebral osteomyelitis [ Time Frame: within 6 weeks after the diagnosis of vertebral osteomyelitis ]

Secondary Outcome Measures:
  • Unfavorable outcomes (death or permanent neurologic deficit) [ Time Frame: within 6 months after the diagnosis of vertebral osteomyelitis ]

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

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sang-Ho Choi, Doctor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01125839     History of Changes
Other Study ID Numbers: AVOMS
First Submitted: May 18, 2010
First Posted: May 19, 2010
Last Update Posted: February 25, 2014
Last Verified: September 2013

Keywords provided by Sang-Ho Choi, Asan Medical Center:
osteomyelitis
16S rRNA
spine
Magnetic resonance imaging

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