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

May 18, 2010
February 24, 2014
May 2010
December 2013   (final data collection date for primary outcome measure)
Identification of etiology of vertebral osteomyelitis [ Time Frame: within 6 weeks after the diagnosis of vertebral osteomyelitis ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01125839 on ClinicalTrials.gov Archive Site
Unfavorable outcomes (death or permanent neurologic deficit) [ Time Frame: within 6 months after the diagnosis of vertebral osteomyelitis ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Characterization and Differential Diagnosis of Vertebral Osteomyelitis
Clinical Features, Microbiological-, Radiological Characteristics, and Differential Diagnosis of Vertebral Osteomyelitis

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

CT guided biopsy specimen

Probability Sample

All patients that have MRI findings sugggestive of vertebral osteomyelitis

Vertebral Osteomyelitis
Not Provided
Spondylitis
Patients who checked spine MRI for back pain
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01125839
AVOMS
Yes
Sang-Ho Choi, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Sang-Ho Choi, MD Asan Medical Center
Asan Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP