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
Recruitment status was Not yet recruiting
Sponsor:
University Medical Centre Ljubljana
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
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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
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 May 19, 2013