## Protocol Section
### Identification Module
**NCT ID:** NCT01438879

**Brief Title:** Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)

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

#### Organization Study ID Info
**ID:** R11077
#### Organization
**Class:** OTHER
**Full Name:** PaijatHame Central Hospital
### Status Module
#### Completion Date
**Date:** 2013-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2011-09-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-09-21

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2013-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2011-10

**Status Verified Date:** 2011-09

#### Study First Post Date
**Date:** 2011-09-22
**Type:** ESTIMATED
**Study First Submit Date:** 2011-09-20
**Study First Submit QC Date:** 2011-09-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Turku

#### Lead Sponsor

**Class:** OTHER

**Name:** PaijatHame Central Hospital

#### Responsible Party

**Investigator Affiliation:** PaijatHame Central Hospital

**Investigator Full Name:** Laura Kupila

**Investigator Title:** Specialist in neurology, MD PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Central Nervous System Infection

**Keywords:**

- CSF

- PCR

- lymphocytic herpesvirus

- CNS

### Design Module

#### Bio Spec

**Description:** CSF white cells + CSF supernatant, Blood white cells and serum

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 40 patients with clinical signs of CNS infection and having CSF pleocytosis.

**Label:** pleocytosis group

#### Arm Group 2

**Description:** 20 patients not having CNS infection clinically and not having CSF pleocytosis.

**Label:** non-pleocytosis group

### 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)

**Maximum Age:** 80 Years

**Minimum Age:** 16 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Residents of the district of Paijat-Hame (200 000 inhabitants).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** laura.kupila@phsotey.fi

**Name:** Laura MA Kupila

**Phone:** +358447195940

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Lahti

**Contacts:**

***Contact 1:***

- **Email:** laura.kupila@phsotey.fi

- **Name:** Laura Kupila

- **Role:** CONTACT

***Contact 2:***

- **Name:** Laura Kupila

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Finland

**Facility:** PaijatHame Central Hospital

**Zip:** 15850

#### Overall Officials

**Official 1:**

**Affiliation:** PaijatHame Central Hospital

**Name:** Laura MA Kupila

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5743

- Name: Central Nervous System Infections

- Relevance: HIGH

- As Found: Central Nervous System Infections

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000002494

- Term: Central Nervous System Infections

### Misc Info Module

- Version Holder: 2024-05-24
