SWEtick - a Prospective Multicenter Study of Tick-borne Diseases in Sweden

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorRegion Jönköping County

About this trial

The purpose of the SWEtick project is to increase the knowledge of the various clinical presentations of emerging tick-borne diseases (eTBD), to assess their importance for human health, to develop and validate laboratory methods for diagnosis of eTBD, and to develop recommendations for knowledge-driven management of patients with suspected eTBD within the Swedish healthcare system.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Clinical suspicion of tick-borne disease (physician's assessment based on medical history, symptoms, clinical findings and sometimes laboratory results)

Disqualifiers

Incapacitated to understand the study information and make decisions (adults and adolescents >15 years)

Trial population

1. Medical history: tick exposure, tick bite, splenectomy, immunosuppressive treatment (e.g. anti-CD20 or other biological/immunomodulatory drugs, cortisone corresponding to \>10 mg prednisolone/day, chemotherapy, hematologic malignancy, other malignancy, rheumatologic disease) 2. Symptoms/clinical signs: fever after tick bite, relapsing fever of unknown origin, skin rashes (single/multiple erythema migrans, lymphocytoma, acrodermatitis chronica atrophicans or other), venous thrombosis, repeated thrombophlebitis, meningitis, encephalitis, myelitis, cranial nerve palsy, radiculitis, peripheral nerve involvment, mono-/oligoarthritis, carditis, ocular or otogenic disturbances of uncertain origin where medical history includes recent tick bite. 3. Biochemical findings in combination with factors under a) and b): leukopenia, thrombocytopenia, anemia, elevated liver enzymes, slightly elevated erythrocyte sedimentation rate and/or C-reactive protein, pleocytosis in CSF or synovial fluid.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 5 trial groups
Group A: TBD
Group B: Non-TBD
Group C: Control group CNS
Group D: Control group arthritis
Group E: Control group healthy

Trial outcomes

Primary outcomes

1

EuroQoL-5 Dimension Questionnaire (EQ-5D)

Difference in EQ-5D Health index between study inclusion and at the 6 month-follow-up

Time frame
6 months
2

Visual Analogue Scale for Health (VAS)

Difference between the VAS units at study inclusion and at 6 month-follow-up.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Jönköping County

Lead sponsor

Region Östergötland

Collaborator

Region Kalmar County

Collaborator

Region Dalarna

Collaborator

FORSS - The Research Council of South-Eastern Sweden

Collaborator

ALF Grants, Region Östergötland

Collaborator

Linkoeping University

Collaborator

Region of Uppsala

Collaborator

Region Örebro County

Collaborator

Västra Götalandsregionen

Collaborator