We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Characterization and Differential Diagnosis of Postneurosurgical Meningitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01122537
First Posted: May 13, 2010
Last Update Posted: October 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sang-Ho Choi, Asan Medical Center
  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 Sang-Ho Choi, Asan Medical Center:

Primary Outcome Measures:
  • Development of meningitis [ Time Frame: within 4 weeks after neurosurgical operation ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: within 4 weeks after the diagnosis of meningitis ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sang-Ho Choi, Doctor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01122537     History of Changes
Other Study ID Numbers: APNSM
First Submitted: May 11, 2010
First Posted: May 13, 2010
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by Sang-Ho Choi, Asan Medical Center:
Meningitis
infection
cerebrospinal fluid
procalcitonin
adenosine deaminase

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