NCT01438879

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 22, 2011

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

September 20, 2011

Last Update Submit

September 21, 2011

Conditions

Keywords

CSFPCRlymphocytic herpesvirusCNS

Study Arms (2)

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 Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PaijatHame Central Hospital

Lahti, 15850, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Central Nervous System Infections

Condition Hierarchy (Ancestors)

InfectionsCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Laura MA Kupila

    PaijatHame Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in neurology, MD PhD

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 22, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

September 22, 2011

Record last verified: 2011-09

Locations