Central European EncephalitisNCT00941590
Postencephalitic Symptoms After Tick Borne Encephalitis
An observational study of Central European Encephalitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to assess clinical outcome in patients with tick borne encephalitis. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central European Encephalitis
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- Jul 2009to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with tick borne encephalitis
Who may be able to join
- serologically proved tick borne encephalitis in patients > 15 years
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1525
About this study
The purpose of this study is to assess clinical outcome in patients with tick borne encephalitis.
- Conditions
- Central European Encephalitis
- Keywords
- tick borne encephalitis, clinical outcome, postencephalitic symptoms
- Medical subject headings
- Encephalitis, Tick-Borne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with tick borne encephalitis. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective sequelae and subjective symptoms in patients after tick borne encephalitis.
Measured: 1 year follow-up.
Secondary outcomes (1)
Comparison of subjective symptoms between patients after tick borne encephalitis and control subjects without a history of tick borne encephalitis.
Measured: 1 year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central European EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Investigators
- Franc Strle, MD PhD, Study chair, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941590
- Sponsor's protocol ID
- POST-KME
- Status last verified
- Jul 2009
- First submitted
- 16 Jul 2009
- Last updated
- 17 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postencephalitic Symptoms After Tick Borne Encephalitis
- ClinicalTrials.gov ID
- NCT00941590
- Acronym / sponsor ID
- POST-KME
- Conditions
- Central European Encephalitis
- Keywords
- tick borne encephalitis, clinical outcome, postencephalitic symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2010 (estimated)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess clinical outcome in patients with tick borne encephalitis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with tick borne encephalitis. | – | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with tick borne encephalitis
Key inclusion criteria (1 listed)
- serologically proved tick borne encephalitis in patients > 15 years
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective sequelae and subjective symptoms in patients after tick borne encephalitis.
Time frame: 1 year follow-up.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franc Strle, MD PhD study chair
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central European Encephalitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarina Ogrinc, MD PhD (+386 1 522 4217, katarina.ogrinc1@guest.arnes.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective sequelae and subjective symptoms in patients after tick borne encephalitis. (time frame: 1 year follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2009; AzTrials last refreshed its copy on 30 Oct 2026.