Postencephalitic Symptoms After Tick Borne Encephalitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Medical Centre Ljubljana.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00941590
First received: July 16, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

The purpose of this study is to assess clinical outcome in patients with tick borne encephalitis.


Condition
Central European Encephalitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Postencephalitic Symptoms After Tick Borne Encephalitis

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Objective sequelae and subjective symptoms in patients after tick borne encephalitis. [ Time Frame: 1 year follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of subjective symptoms between patients after tick borne encephalitis and control subjects without a history of tick borne encephalitis. [ Time Frame: 1 year follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with tick borne encephalitis.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients with tick borne encephalitis

Criteria

Inclusion Criteria:

  • serologically proved tick borne encephalitis in patients > 15 years

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941590

Contacts
Contact: Katarina Ogrinc, MD PhD +386 1 522 4217 katarina.ogrinc1@guest.arnes.si
Contact: Franc Strle, PhD MD +386 1 522 2110 franc.strle@kclj.si

Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Franc Strle, MD PhD UMC Ljubljana
  More Information

No publications provided

Responsible Party: Katarina Ogrinc, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00941590     History of Changes
Other Study ID Numbers: POST-KME
Study First Received: July 16, 2009
Last Updated: July 16, 2009
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
tick borne encephalitis
clinical outcome
postencephalitic symptoms

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
Tick-Borne Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 16, 2014