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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 16, 2009 | ||||||||
| Last Updated Date | July 16, 2009 | ||||||||
| Start Date ICMJE | July 2009 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Objective sequelae and subjective symptoms in patients after tick borne encephalitis. [ Time Frame: 1 year follow-up. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Postencephalitic Symptoms After Tick Borne Encephalitis | ||||||||
| Official Title ICMJE | Postencephalitic Symptoms After Tick Borne Encephalitis | ||||||||
| Brief Summary | The purpose of this study is to assess clinical outcome in patients with tick borne encephalitis. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | patients with tick borne encephalitis |
||||||||
| Condition ICMJE | Central European Encephalitis | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Patients with tick borne encephalitis. | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 15 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Slovenia | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00941590 | ||||||||
| Other Study ID Numbers ICMJE | POST-KME | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Katarina Ogrinc, University Medical Centre Ljubljana | ||||||||
| Study Sponsor ICMJE | University Medical Centre Ljubljana | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University Medical Centre Ljubljana | ||||||||
| Verification Date | July 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||