Postencephalitic Symptoms After Tick Borne Encephalitis | NCT00941590

Studies
Postencephalitic Symptoms After Tick Borne Encephalitis

NCT00941590

Sponsor

University Medical Centre Ljubljana

Status

Unknown status

Last Update Posted

Jul 17, 2009Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Central European Encephalitis

Interventions

Not provided

Countries

Slovenia

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

Jul 2009

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

Jul 2009

Primary Completion Date

Oct 2010Estimated

Completion Date

Not provided

First Submitted Date

Jul 16, 2009

First Submission Date that Met QC Criteria

Jul 16, 2009

First Posted Date

Jul 17, 2009Estimated

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

Jul 16, 2009

Last Update Posted Date

Jul 17, 2009Estimated

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

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

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Patients with tick borne encephalitis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective sequelae and subjective symptoms in patients after tick borne encephalitis.		1 year follow-up.

Secondary Outcomes

Measure	Description	Time Frame
Comparison of subjective symptoms between patients after tick borne encephalitis and control subjects without a history of tick borne encephalitis.		1 year follow-up.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

serologically proved tick borne encephalitis in patients > 15 years

Exclusion Criteria:

pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with tick borne encephalitis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katarina Ogrinc, MD PhD	Contact	+386 1 522 4217		katarina.ogrinc1@guest.arnes.si
Franc Strle, PhD MD	Contact	+386 1 522 2110		franc.strle@kclj.si

Overall Officials

Name	Affiliation	Role
Franc Strle, MD PhD	UMC Ljubljana	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMC Ljubljana, Department of Infectious Diseases		Ljubljana		1525	Slovenia

Condition Browse Module

MeSH Terms

ID	Term
D004675	Encephalitis, Tick-Borne

Ancestor Terms

ID	Term
D004671	Encephalitis, Arbovirus
D018792	Encephalitis, Viral
D020805	Central Nervous System Viral Diseases
D002494	Central Nervous System Infections

Browse Leaves

Not provided

Browse Branches

Not provided