Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by PaijatHame Central Hospital.
Recruitment status was  Not yet recruiting
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
  Purpose

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
Central Nervous System Infection

Study Type: Observational
Study Design: 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

Further study details as provided by PaijatHame Central Hospital:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438879

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

Locations
Finland
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
Investigators
Principal Investigator: Laura MA Kupila PaijatHame Central Hospital
  More Information

No publications provided

Responsible Party: Laura Kupila, Specialist in neurology, MD PhD, PaijatHame Central Hospital
ClinicalTrials.gov Identifier: NCT01438879     History of Changes
Other Study ID Numbers: R11077
Study First Received: September 20, 2011
Last Updated: September 21, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by PaijatHame Central Hospital:
CSF
PCR
lymphocytic herpesvirus
CNS

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

ClinicalTrials.gov processed this record on October 21, 2014