Vertebral OsteomyelitisNCT01125839
Characterization and Differential Diagnosis of Vertebral Osteomyelitis
An observational study of Vertebral Osteomyelitis, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Vertebral Osteomyelitis
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that have MRI findings sugggestive of vertebral osteomyelitis
Who may be able to join
- Symptoms or signs consistent with spinal column infection
- MRI findings suggestive of infection
- Antibiotic treatment for vertebral myelitis
Who cannot join
- Patients already treated more than 2 weeks for osteomyelitis in transferring hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Features, Microbiological-, Radiological Characteristics, and Differential Diagnosis of Vertebral Osteomyelitis
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.
Read the 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.
- Conditions
- Vertebral Osteomyelitis
- Keywords
- osteomyelitis, 16S rRNA, spine, Magnetic resonance imaging
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spondylitis | Patients who checked spine MRI for back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of etiology of vertebral osteomyelitis
Measured: within 6 weeks after the diagnosis of vertebral osteomyelitis
Secondary outcomes (1)
Unfavorable outcomes (death or permanent neurologic deficit)
Measured: within 6 months after the diagnosis of vertebral osteomyelitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral OsteomyelitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Ho Choi, Asan Medical Center
- Investigators
- Sang-Ho Choi, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125839
- Sponsor's protocol ID
- AVOMS
- Status last verified
- Sep 2013
- First submitted
- 18 May 2010
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features, Microbiological-, Radiological Characteristics, and Differential Diagnosis of Vertebral Osteomyelitis
- ClinicalTrials.gov ID
- NCT01125839
- Acronym / sponsor ID
- AVOMS
- Conditions
- Vertebral Osteomyelitis
- Keywords
- osteomyelitis, 16S rRNA, spine, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spondylitis | – | –Patients who checked spine MRI for back pain |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that have MRI findings sugggestive of vertebral osteomyelitis
Key inclusion criteria (3 listed)
- Symptoms or signs consistent with spinal column infection
- MRI findings suggestive of infection
- Antibiotic treatment for vertebral myelitis
Key exclusion criteria (1 listed)
- Patients already treated more than 2 weeks for osteomyelitis in transferring hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of etiology of vertebral osteomyelitis
Time frame: within 6 weeks after the diagnosis of vertebral osteomyelitis
1 secondary outcome
Unfavorable outcomes (death or permanent neurologic deficit)
Time frame: within 6 months after the diagnosis of vertebral osteomyelitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
Related trials for Vertebral Osteomyelitis
Recruiting
Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department
Spinal Stenosis, SPINAL Fracture
RecruitingObservational study
INfectious DIsease REgistry BIObank
Bloodstream Infections, Central Nervous System Infections
Enrolling by invitationObservational study
Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis
Infectious; Spondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Ho Choi, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Osteomyelitis, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of etiology of vertebral osteomyelitis (time frame: within 6 weeks after the diagnosis of vertebral osteomyelitis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.