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

March 3, 2026 updated by: Anna J Henningsson, Region Jönköping County

Emerging Tick-borne Diseases in Children and Adults in Sweden (SWEtick): a Prospective Multicenter Study for Improved Patient Management

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Johanna Sjöwall, Associate Professor (docent)
  • Phone Number: 46 10 104 08 94
  • Email: johanna.sjowall@liu.se

Study Locations

  • Sweden
    • Region Dalarna
      • Falun, Region Dalarna, Sweden
        • Recruiting
        • Department of Paediatrics
        • Contact:
        • Principal Investigator:
          • Barbro Hedin Skogman, M.D., Ph.D.
    • Region Jönköping County
      • Eksjö, Region Jönköping County, Sweden, 575 81
        • Recruiting
        • Department of Paediatrics, Eksjö Hospital
        • Principal Investigator:
          • Henrik Hillerdal, M.D.
        • Contact:
      • Jönköping, Region Jönköping County, Sweden, 55185
        • Recruiting
        • Department of Infectious Diseases, County Hospital Ryhov
        • Contact:
        • Principal Investigator:
          • Paula Gyllemark, M.D., Ph.D.
      • Jönköping, Region Jönköping County, Sweden, 55185
        • Recruiting
        • Department of Paediatrics
        • Principal Investigator:
          • Henrik Hillerdal, M.D.
        • Contact:
    • Region Kalmar County
      • Kalmar, Region Kalmar County, Sweden, 392 56
        • Recruiting
        • Department of Infectious Diseases, Kalmar County Hospital
        • Principal Investigator:
          • Mats Haglund, M.D., Ph.D.
        • Contact:
    • Region Uppsala
      • Uppsala, Region Uppsala, Sweden
        • Not yet recruiting
        • Department of Infectious Diseases
        • Contact:
        • Principal Investigator:
          • Marie Edvinsson, M.D., Ph.D.
        • Sub-Investigator:
          • Elisabet Skoog, M.D.
      • Uppsala, Region Uppsala, Sweden
        • Not yet recruiting
        • Department of Paediatrics
        • Contact:
        • Principal Investigator:
          • Josefin Årling, M.D.
    • Region Örebro County
      • Örebro, Region Örebro County, Sweden
        • Not yet recruiting
        • Department of Paediatrics
        • Contact:
        • Principal Investigator:
          • Andreas Ohlin, M.D.
    • Region Östergötland
      • Linköping, Region Östergötland, Sweden, 581 85
        • Recruiting
        • Department of Infectious Diseases, Linköping University Hospital
        • Contact:
        • Principal Investigator:
          • Johanna Sjöwall, Associate Professor (Docent)
      • Norrköping, Region Östergötland, Sweden, 603 79
        • Recruiting
        • Department of Infectious Diseases, Vrinnevi Hospital
        • Contact:
        • Principal Investigator:
          • Johanna Sjöwall, Associate Professor (Docent)
      • Norrköping, Region Östergötland, Sweden, 603 79
        • Recruiting
        • Department of Paediatrics, Vrinnevi Hospital
        • Contact:
        • Principal Investigator:
          • Maria Nordvall, M.D.
    • Västra Götalandsregionen
      • Skövde, Västra Götalandsregionen, Sweden
        • Not yet recruiting
        • Department of Paediatrics
        • Contact:
        • Principal Investigator:
          • Carl-Johan Törnhage, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study 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.

Description

Inclusion Criteria in TBD and Non-TBD groups:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TBD
Patients with confirmed tick-borne disease
Non-TBD
Patients investigated for suspected tick-borne disease but diagnosed with another condition (tick-borne disease excluded)
Control group CNS
Patients obtaining spinal anasthesia in conjunction with knee or hip replacement surgery due to arthrosis
Control group arthritis
Patients with autoinflammatory joint disease
Control group healthy
Blood donors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQoL-5 Dimension Questionnaire (EQ-5D)
Time Frame: 6 months
Difference in EQ-5D Health index between study inclusion and at the 6 month-follow-up
6 months
Visual Analogue Scale for Health (VAS)
Time Frame: 6 months
Difference between the VAS units at study inclusion and at 6 month-follow-up.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Jönköping County

Collaborators

Linkoeping University
Region Östergötland
Region Örebro County
Västra Götalandsregionen
Region Kalmar County
Region Dalarna
FORSS - The Research Council of South-Eastern Sweden
ALF Grants, Region Östergötland
Region of Uppsala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPM 2022-05330-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication can be shared after anonymization, upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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