NCT00524108

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

Enrollment Period

3.3 years

First QC Date

August 31, 2007

Last Update Submit

August 14, 2012

Conditions

Ventriculoperitoneal ShuntInfection

Keywords

shuntinternal ventriculoperitoneal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

VP shunt infection

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with meningitis from community acquired organisms (e.g. Streptococcus pneumoniae, Neisseria meningitidis, Listeria monocytogenes and Haemophilus Influenzae).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Adarsh Bhimraj, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 3, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations

US(1)