Characterization and Differential Diagnosis of Vertebral Osteomyelitis
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01125839 |
Recruitment Status
:
Completed
First Posted
: May 19, 2010
Last Update Posted
: February 25, 2014
|
Sponsor:
Asan Medical Center
Information provided by (Responsible Party):
Sang-Ho Choi, Asan Medical Center
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 |
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 |
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 |
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:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
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 |
|
|||
PRS Account | Asan Medical Center | |||
Verification Date | September 2013 |