Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)

This study is not yet open for participant recruitment.

Verified September 2011 by PaijatHame Central Hospital

Sponsor:

Collaborator:

University of Turku

Information provided by (Responsible Party):

Laura Kupila, PaijatHame Central Hospital

ClinicalTrials.gov Identifier:

NCT01438879

First received: September 20, 2011

Last updated: September 21, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 20, 2011

Last Updated Date

September 21, 2011

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01438879 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

CSF white cells + CSF supernatant, Blood white cells and serum

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Central Nervous System Infection

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

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 ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

16 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Laura MA Kupila

+358447195940

laura.kupila@phsotey.fi

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01438879

Other Study ID Numbers ^ICMJE

R11077

Has Data Monitoring Committee

Responsible Party

Laura Kupila, PaijatHame Central Hospital

Study Sponsor ^ICMJE

PaijatHame Central Hospital

Collaborators ^ICMJE

University of Turku

Investigators ^ICMJE

Principal Investigator:

Laura MA Kupila

PaijatHame Central Hospital

Information Provided By

PaijatHame Central Hospital

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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