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Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)

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ClinicalTrials.gov Identifier: NCT01438879
Recruitment Status : Unknown
Verified September 2011 by Laura Kupila, PaijatHame Central Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2011
Last Update Posted : September 22, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Central Nervous System Infection

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecular Methods in the Etiological Diagnostics of Acute Central Nervous System Infections: Lymphocytic Herpesviruses and PCR
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013
Groups and Cohorts

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.

Outcome Measures

Biospecimen Retention:   Samples With DNA
CSF white cells + CSF supernatant, Blood white cells and serum

Eligibility Criteria

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents of the district of Paijat-Hame (200 000 inhabitants).

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438879

Contact: Laura MA Kupila +358447195940 laura.kupila@phsotey.fi

PaijatHame Central Hospital Not yet recruiting
Lahti, Finland, 15850
Contact: Laura Kupila       laura.kupila@phsotey.fi   
Principal Investigator: Laura Kupila         
Sponsors and Collaborators
PaijatHame Central Hospital
University of Turku
Principal Investigator: Laura MA Kupila PaijatHame Central Hospital
More Information

Responsible Party: Laura Kupila, Specialist in neurology, MD PhD, PaijatHame Central Hospital
ClinicalTrials.gov Identifier: NCT01438879     History of Changes
Other Study ID Numbers: R11077
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011

Keywords provided by Laura Kupila, PaijatHame Central Hospital:
lymphocytic herpesvirus

Additional relevant MeSH terms:
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases