NCT01122537

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

3.3 years

First QC Date

May 11, 2010

Last Update Submit

September 29, 2013

Conditions

Neurosurgery

Keywords

Meningitisinfectioncerebrospinal fluidprocalcitoninadenosine deaminase

Outcome Measures

Primary Outcomes (1)

  • Development of meningitis

    within 4 weeks after neurosurgical operation

Secondary Outcomes (1)

  • All-cause mortality

    within 4 weeks after the diagnosis of meningitis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patient who develop meningitis after neurosurgical operation

You may qualify if:

  • Cerebrospinal fluid corrected WBC \>6/mm\^3 and/or fever (\> 38℃) and/or neck stiffness

You may not qualify if:

  • Patients already treated more than 48 hours for meningitis before cerebrospinal fluid examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

MeningitisInfections

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System Diseases

Study Officials

  • Sang-Ho Choi, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 13, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

KR(1)