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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 18, 2010

Last Updated Date

February 24, 2014

Start Date ^ICMJE

May 2010

Primary Completion Date

December 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.

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Vertebral Osteomyelitis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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 ^ICMJE

Completed

Estimated Enrollment ^ICMJE

100

Completion Date

December 2013

Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01125839

Other Study ID Numbers ^ICMJE

AVOMS

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Sang-Ho Choi, Asan Medical Center

Study Sponsor ^ICMJE

Asan Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sang-Ho Choi, MD

Asan Medical Center

Information Provided By

Asan Medical Center

Verification Date

September 2013

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

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