Characterization and Differential Diagnosis of Postneurosurgical Meningitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sang-Ho Choi, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01122537
First received: May 11, 2010
Last updated: September 29, 2013
Last verified: September 2013
  Purpose

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.


Condition
Neurosurgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Features, Microbiological Characteristics, and Differential Diagnosis of Postneurosurgical Meningitis

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Development of meningitis [ Time Frame: within 4 weeks after neurosurgical operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: within 4 weeks after the diagnosis of meningitis ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: May 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patient who develop meningitis after neurosurgical operation

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01122537

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Sang-Ho Choi, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Sang-Ho Choi, Doctor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01122537     History of Changes
Other Study ID Numbers: APNSM
Study First Received: May 11, 2010
Last Updated: September 29, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Meningitis
infection
cerebrospinal fluid
procalcitonin
adenosine deaminase

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014