Characterization and Differential Diagnosis of Vertebral Osteomyelitis
| Tracking Information | |||||
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| First Received Date ICMJE | May 18, 2010 | ||||
| Last Updated Date | February 11, 2013 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Identification of etiology of vertebral osteomyelitis [ Time Frame: within 6 weeks after the diagnosis of vertebral osteomyelitis ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01125839 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Unfavorable outcomes (death or permanent neurologic deficit) [ Time Frame: within 6 months after the diagnosis of vertebral osteomyelitis ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Characterization and Differential Diagnosis of Vertebral Osteomyelitis | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: CT guided biopsy specimen |
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| Sampling Method | Probability Sample | ||||
| Study Population | All patients that have MRI findings sugggestive of vertebral osteomyelitis |
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| Condition ICMJE | Vertebral Osteomyelitis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Spondylitis
Patients who checked spine MRI for back pain |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | April 2013 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01125839 | ||||
| Other Study ID Numbers ICMJE | AVOMS | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Sang-Ho Choi, Asan Medical Center | ||||
| Study Sponsor ICMJE | Asan Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Asan Medical Center | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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