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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01122537
Other study ID # APNSM
Secondary ID
Status Completed
Phase N/A
First received May 11, 2010
Last updated September 29, 2013
Start date May 2010
Est. completion date September 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

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


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 Development of meningitis within 4 weeks after neurosurgical operation No
Secondary All-cause mortality within 4 weeks after the diagnosis of meningitis No
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