Characterization and Differential Diagnosis of Vertebral Osteomyelitis

Vertebral Osteomyelitis Clinical Trial

Official title:

Clinical Features, Microbiological-, Radiological Characteristics, and Differential Diagnosis of Vertebral Osteomyelitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125839
• Other study ID #: AVOMS
• Status: Completed
• Phase: N/A
• First received: May 18, 2010
• Last updated: February 24, 2014
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteomyelitis
• Vertebral Osteomyelitis

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of etiology of vertebral osteomyelitis		within 6 weeks after the diagnosis of vertebral osteomyelitis	No
Secondary	Unfavorable outcomes (death or permanent neurologic deficit)		within 6 months after the diagnosis of vertebral osteomyelitis	No