Characterization and Differential Diagnosis of Vertebral Osteomyelitis

Tracking Information
First Submitted Date	May 18, 2010
First Posted Date	May 19, 2010
Last Update Posted Date	February 25, 2014
Study Start Date	May 2010
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: May 18, 2010)	Identification of etiology of vertebral osteomyelitis [ Time Frame: within 6 weeks after the diagnosis of vertebral osteomyelitis ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01125839 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: May 18, 2010)	Unfavorable outcomes (death or permanent neurologic deficit) [ Time Frame: within 6 months after the diagnosis of vertebral osteomyelitis ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Characterization and Differential Diagnosis of Vertebral Osteomyelitis
Official Title	Clinical Features, Microbiological-, Radiological Characteristics, and Differential Diagnosis of Vertebral Osteomyelitis
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.
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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: CT guided biopsy specimen
Sampling Method	Probability Sample
Study Population	All patients that have MRI findings sugggestive of vertebral osteomyelitis
Condition	Vertebral Osteomyelitis
Intervention	Not Provided
Study Groups/Cohorts	Spondylitis; Patients who checked spine MRI for back pain
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: May 18, 2010)	100
Original Estimated Enrollment	Same as current
Actual Study Completion Date	December 2013
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	16 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number	NCT01125839
Other Study ID Numbers	AVOMS
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Sang-Ho Choi, Asan Medical Center
Study Sponsor	Asan Medical Center
Collaborators	Not Provided
Investigators	Principal Investigator: Sang-Ho Choi, MD Asan Medical Center
PRS Account	Asan Medical Center
Verification Date	September 2013