- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01122537
Characterization and Differential Diagnosis of Postneurosurgical Meningitis
September 29, 2013 updated by: Sang-Ho Choi, Asan Medical Center
Clinical Features, Microbiological Characteristics, and Differential Diagnosis of Postneurosurgical Meningitis
Meningitis is a rare complication following neurosurgical procedures and is associated with high morbidity and mortality.
The aim of this study is to describe the clinical characteristics and microbiological characteristics in patients who develope meningitis following neurosurgical operations, and investigate the useful tips for the differential diagnosis of postneurosurgical meningitis.
Study Overview
Status
Completed
Conditions
Detailed Description
Besides description of characteristics of patients with postneurosurgical patients, we also will investigate the usefulness of prolonged cerebrospinal fluid (CSF) culture, and profiles of blood and CSF inflammatory markers for the differential diagnosis of meningitis.
CSF culture will be extended upto 2 weeks.
Serum procalcitonin and C-reactive protein, CSF adenosine deaminase levels will be monitored and analyzed for the differential diagnosis of meningitis.
Study Type
Observational
Enrollment (Actual)
78
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patient who develop meningitis after neurosurgical operation
Description
Inclusion Criteria:
- Cerebrospinal fluid corrected WBC >6/mm^3 and/or fever (> 38℃) and/or neck stiffness
Exclusion Criteria:
- Patients already treated more than 48 hours for meningitis before cerebrospinal fluid examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of meningitis
Time Frame: within 4 weeks after neurosurgical operation
|
within 4 weeks after neurosurgical operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause mortality
Time Frame: within 4 weeks after the diagnosis of meningitis
|
within 4 weeks after the diagnosis of meningitis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sang-Ho Choi, MD, Asan Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
May 11, 2010
First Submitted That Met QC Criteria
May 11, 2010
First Posted (Estimate)
May 13, 2010
Study Record Updates
Last Update Posted (Estimate)
October 1, 2013
Last Update Submitted That Met QC Criteria
September 29, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APNSM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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