Ventriculoperitoneal ShuntNCT00524108
Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infectionsin Adults
An observational study of Ventriculoperitoneal Shunt and Infection, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventriculoperitoneal Shunt, Infection
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: VP shunt infection
Who may be able to join
- 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.
Who cannot join
- Patients with meningitis from community acquired organisms (e.g. Streptococcus pneumoniae, Neisseria meningitidis, Listeria monocytogenes and Haemophilus Influenzae).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventriculoperitoneal Shunt, Infection
- Keywords
- shunt, internal ventriculoperitoneal
- Medical subject headings
- Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventriculoperitoneal ShuntStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adarsh Bhimraj, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524108
- Sponsor's protocol ID
- PRO07080212
- Status last verified
- Aug 2012
- First submitted
- 31 Aug 2007
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Clinical Features in Ventriculoperitoneal Shunt Infections and Time to Re-Implantation in Adults
- ClinicalTrials.gov ID
- NCT00524108
- Acronym / sponsor ID
- PRO07080212
- Conditions
- Ventriculoperitoneal Shunt, Infection
- Keywords
- shunt, internal ventriculoperitoneal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- VP shunt infection
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with meningitis from community acquired organisms (e.g. Streptococcus pneumoniae, Neisseria meningitidis, Listeria monocytogenes and Haemophilus Influenzae).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adarsh Bhimraj, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventriculoperitoneal Shunt and Infection, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.