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Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infectionsin Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00524108
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : August 16, 2012
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh

Tracking Information
First Submitted Date August 31, 2007
First Posted Date September 3, 2007
Last Update Posted Date August 16, 2012
Study Start Date August 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infectionsin Adults
Official Title 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 Observational
Study Design 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
  • Ventriculoperitoneal Shunt
  • Infection
Intervention Not Provided
Study Groups/Cohorts 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 Completed
Actual Enrollment
 (submitted: August 14, 2012)
350
Original Estimated Enrollment
 (submitted: August 31, 2007)
500
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00524108
Other Study ID Numbers PRO07080212
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Not Provided
Investigators
Principal Investigator: Adarsh Bhimraj, MD University of Pittsburgh Medical Center
PRS Account University of Pittsburgh
Verification Date August 2012