- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05941546
Tick-borne Encephalitis Virus Research in Limousin (VITAL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Limoges, France, 87000
- Limoges University Hosiptal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with Lyme serology. Neurological picture compatible with neuroborreliosis or encephalitis.
- No objection from the patient to the use of biobank samples
Exclusion Criteria:
- Patient's opposition.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of anti-TBEV antibodies in serum
Time Frame: month 1
|
The primary endpoint is the detection of anti-TBEV antibodies in the serum of the study population.
|
month 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Search for the presence of TBEV in the CSF in case of positive serology. Determine the risk factors associated with this infection.
Time Frame: month 2
|
the detection of TBEV RNA will be carried out by real-time RT-PCR in the CSF of patients with positive anti-TBEV serology (if associated CSF available). The analysis will be qualitative in order to obtain a positive/negative response on the presence of virus RNA in the sample. In order to obtain information on the context of the infection, a questionnaire will be sent to TBEV-positive patients. |
month 2
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infectious Encephalitis
- Vector Borne Diseases
- Neuroinflammatory Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Arbovirus Infections
- Flavivirus Infections
- Flaviviridae Infections
- Tick-Borne Diseases
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Encephalitis
- Encephalitis, Arbovirus
- Encephalitis, Tick-Borne
Other Study ID Numbers
- 87RI23_0012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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