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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Jönköping County

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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