Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)

September 21, 2011 updated by: Laura Kupila, PaijatHame Central Hospital

Molecular Methods in the Etiological Diagnostics of Acute Central Nervous System Infections: Lymphocytic Herpesviruses and PCR

Enterovirus and herpes simplex viruses 1 and 2 are the main causative agents of central nervous system infections.

Instead, the role of lymphocytic herpesviruses in the etiology of central nervous system (CNS) infections is not clear, even if there is the positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR)-result for the virus.

The aim of this study is to evaluate the presence of DNA from lymphocytic herpesviruses in the CSF obtained from the immunocompetent patients with CSF pleocytosis and from the patients with normal CSF leukocyte count.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents of the district of Paijat-Hame (200 000 inhabitants).

Description

Inclusion Criteria:

  • Immunocompetent patients with clinical symptoms and signs of central nervous system infections and CSF pleocytosis (pleocytosis group)
  • Immunocompetent patients without suspicion of CNS infection and no CSF pleocytosis (non-pleocytosis group)

Exclusion Criteria:

  • Suspicion of CNS-infection, eg. encephalitis, but no CSF leukocytosis (pleocytosis group)
  • Patients without symptoms of CNS infection, but who has CSF pleocytosis of unknown origin (non-pleocytosis group)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pleocytosis group
40 patients with clinical signs of CNS infection and having CSF pleocytosis.
non-pleocytosis group
20 patients not having CNS infection clinically and not having CSF pleocytosis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PaijatHame Central Hospital

Collaborators

University of Turku

Investigators

  • Principal Investigator: Laura MA Kupila, PaijatHame Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 21, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R11077

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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