Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infectionsin Adults

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00524108

First received: August 31, 2007

Last updated: August 14, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2007

Last Updated Date

August 14, 2012

Start Date ^ICMJE

August 2007

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00524108 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infectionsin Adults

Official Title ^ICMJE

Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infections and Time to Re-Implantation in Adults

Brief Summary

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

VP shunt infection

Condition ^ICMJE

Ventriculoperitoneal Shunt
Infection

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

350

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00524108

Other Study ID Numbers ^ICMJE

PRO07080212

Has Data Monitoring Committee

Yes

Responsible Party

University of Pittsburgh

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Adarsh Bhimraj, MD

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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