Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymer... | NCT01438879

Studies
Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)

NCT01438879

Sponsor

PaijatHame Central Hospital

Status

Unknown status

Last Update Posted

Sep 22, 2011Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Central Nervous System Infection

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Oct 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Sep 20, 2011

First Submission Date that Met QC Criteria

Sep 21, 2011

First Posted Date

Sep 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2011

Last Update Posted Date

Sep 22, 2011Estimated

Name	Class
University of Turku	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laura MA Kupila	Contact	+358447195940		laura.kupila@phsotey.fi

Overall Officials

Name	Affiliation	Role
Laura MA Kupila	PaijatHame Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PaijatHame Central Hospital		Lahti		15850	Finland

Condition Browse Module

MeSH Terms

ID	Term
D002494	Central Nervous System Infections

Ancestor Terms

ID	Term
D007239	Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided