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:
PaijatHame Central Hospital
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
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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
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 Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013