NeurosurgeryNCT01122537
Characterization and Differential Diagnosis of Postneurosurgical Meningitis
An observational study of Neurosurgery, run by Asan Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neurosurgery
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient who develop meningitis after neurosurgical operation
Who may be able to join
- Cerebrospinal fluid corrected WBC >6/mm^3 and/or fever (> 38℃) and/or neck stiffness
Who cannot join
- Patients already treated more than 48 hours for meningitis before cerebrospinal fluid examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurosurgery
- Keywords
- Meningitis, infection, cerebrospinal fluid, procalcitonin, adenosine deaminase
- Medical subject headings
- Meningitis, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of meningitis
Measured: within 4 weeks after neurosurgical operation
Secondary outcomes (1)
All-cause mortality
Measured: within 4 weeks after the diagnosis of meningitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Ho Choi, Asan Medical Center
- Investigators
- Sang-Ho Choi, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122537
- Sponsor's protocol ID
- APNSM
- Status last verified
- Sep 2013
- First submitted
- 11 May 2010
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features, Microbiological Characteristics, and Differential Diagnosis of Postneurosurgical Meningitis
- ClinicalTrials.gov ID
- NCT01122537
- Acronym / sponsor ID
- APNSM
- Conditions
- Neurosurgery
- Keywords
- Meningitis, infection, cerebrospinal fluid, procalcitonin, adenosine deaminase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient who develop meningitis after neurosurgical operation
Key inclusion criteria (1 listed)
- Cerebrospinal fluid corrected WBC >6/mm^3 and/or fever (> 38℃) and/or neck stiffness
Key exclusion criteria (1 listed)
- Patients already treated more than 48 hours for meningitis before cerebrospinal fluid examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of meningitis
Time frame: within 4 weeks after neurosurgical operation
1 secondary outcome
All-cause mortality
Time frame: within 4 weeks after the diagnosis of meningitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Ho Choi, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurosurgery, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of meningitis (time frame: within 4 weeks after neurosurgical operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.