- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00524108
Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infectionsin Adults
August 14, 2012 updated by: University of Pittsburgh
Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infections and Time to Re-Implantation in Adults
The objectives of this study are:
- To describe the incidence of clinical features in adults with internal ventriculoperitoneal (VP) shunt infections,
- To determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and
- To evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.
Study Overview
Status
Completed
Conditions
Detailed Description
Information from medical records of patients seen by the PI will be collected and analyzed to describe the incidence of clinical features in adults with internal ventriculoperitoneal shunt infections, to determine the validity of laboratory parameters in adults with internal ventriculoperitoneal shunt infections and to evaluate the relationship between the timing of shunt re-implantation with the rates of relapse and secondary infection.
Study Type
Observational
Enrollment (Actual)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
VP shunt infection
Description
Inclusion Criteria:
- Adults (age >= 18 yrs) with VP shunts (ventriculoatrial [VA], and other cerebrospinal fluid [CSF] catheters will not be included).
- Cases will include patients with a diagnosis of VP shunt infection.
- Controls will be patients with a clinical suspicion of shunt infections with negative CSF cultures.
Exclusion Criteria:
- Patients with meningitis from community acquired organisms (e.g. Streptococcus pneumoniae, Neisseria meningitidis, Listeria monocytogenes and Haemophilus Influenzae).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adarsh Bhimraj, MD, University of Pittsburgh Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 31, 2007
First Submitted That Met QC Criteria
August 31, 2007
First Posted (Estimate)
September 3, 2007
Study Record Updates
Last Update Posted (Estimate)
August 16, 2012
Last Update Submitted That Met QC Criteria
August 14, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO07080212
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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