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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00524108
Other study ID # PRO07080212
Secondary ID
Status Completed
Phase N/A
First received August 31, 2007
Last updated August 14, 2012
Start date August 2007
Est. completion date December 2010

Study information

Verified date August 2012
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

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