CNS disease of unknown infectious aetiology
Conditions
Interventions
None listed
Sponsors
National Center Hospital, National Center of Neurology and Psychiatry
Nagasaki University Yamaguchi University Pfizer Orth Serology Testing Laboratory Pfizer Inc(US) Pfizer Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Inpatient or outpatient (more than 1 year of age) of participating hospital at time of diagnosis 2.Diagnosed with CNS disease of unknown infectious aetiology (See Appendix 3 for definition of CNS of unknown infectious aetiology) 3.In the retrospective part of the study, subjects will be enrolled in this study according to the opt-out process, after the ethical committee has approved this process. In the prospective part of the study, evidence of a signed and dated informed consent form indicating that the patient or their legally authorized representative(s) have been informed of all pertinent aspects of the study and agree to participate. 4.In the retrospective part of the study, availability of residual CSF and/or sera sample(s) collected as part of standard of care. In the prospective part of the study, agreement to blood collection.
Exclusion criteria
Exclusion criteria: 1.Previous enrolment in this study for the same episode of the disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of cases of CNS disease of unknown suspected infectious aetiology caused by Tick-Borne Encephalitis Virus (TBEV) | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographics, clinical characteristics, and clinical outcomes of patients diagnosed with TBE Proportions of patients with risk factors per capita (100K persons) The annual incidence rate of TBE in Japan per capita (TBE cases per 100K persons per year) | — |
Countries
Japan
Contacts
Public ContactShunji Ogami
a2healthcare Corporation Clinical Development Division Evidence solution Department
Outcome results
None listed