Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)

Central Nervous System Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01438879
• Other study ID #: R11077
• Status: Not yet recruiting
• Phase: N/A
• First received: September 20, 2011
• Last updated: September 21, 2011
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: September 2011
• Source: PaijatHame Central Hospital
• Contact: Laura MA Kupila
• Phone: +358447195940
• Email: laura.kupila[@]phsotey.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Central Nervous System Infection
• Central Nervous System Infections

Locations

Country	Name	City	State
Finland	PaijatHame Central Hospital	Lahti

Sponsors (2)

Lead Sponsor	Collaborator
PaijatHame Central Hospital	University of Turku

Country where clinical trial is conducted

Finland,