Tick-Borne DiseasesSWEtickNCT06781008
SWEtick - a Prospective Multicenter Study of Tick-borne Diseases in Sweden
An observational study of Tick-Borne Diseases, run by Region Jönköping County at 12 sites in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Tick-Borne Diseases
- How many people
- 600 participants
- Where
- 12 sitesSweden
- Study dates
- 1 Sep 2023to Dec 2035
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical suspicion of tick-borne disease (physician's assessment based on medical history, symptoms, clinical findings and sometimes laboratory results)
Who cannot join
- Incapacitated to understand the study information and make decisions (adults and adolescents >15 years)
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna J Henningsson, Senior Associate Professor contact
12 sites in 1 country
Sweden12 sites, 12 recruiting
- Recruiting
Department of Paediatrics, Eksjö Hospital
Eksjö, Region Jönköping County, 575 81
Frida Tingvall Lampinen, Research nurse, 46 10 243 64 49, henrik.hillerdal@rjl.se
Henrik Hillerdal, M.D.
- Recruiting
Department of Paediatrics
Falun, Region Dalarna
Barbro Hedin Skogman, M.D., Ph.D., +46 23 492000, barbro.hedinskogman@regiondalarna.se
Barbro Hedin Skogman, M.D., Ph.D.
- Recruiting
Department of Infectious Diseases, County Hospital Ryhov
Jönköping, Region Jönköping County, 55185
Olivia Arnsäter, Research nurse, +46 10 242 21 39, olivia.arnsater@rjl.se
Paula Gyllemark, M.D., Ph.D.
- Recruiting
Department of Paediatrics
Jönköping, Region Jönköping County, 55185
Vendela Tolke, Research nurse, +46 10 242 00 00, vendela.tolke@rjl.se
Henrik Hillerdal, M.D.
- Recruiting
Department of Infectious Diseases, Kalmar County Hospital
Kalmar, Region Kalmar County, 392 56
Erika Gustavsson, Research nurse, 46 70 406 78 62, karin.angre@regionkalmar.se
Mats Haglund, M.D., Ph.D.
- Recruiting
Department of Infectious Diseases, Linköping University Hospital
Linköping, Region Östergötland, 581 85
Martina Sönnerbrandt, Research nurse, 46 10 103 00 00, martina.sonnerbrandt@regionostergotland.se
Johanna Sjöwall, Associate Professor (Docent)
- Recruiting
Department of Infectious Diseases, Vrinnevi Hospital
Norrköping, Region Östergötland, 603 79
Annette Gustafsson, Research nurse, +46 10 104 32 60, annette.gustafsson@regionostergotland.se
Johanna Sjöwall, Associate Professor (Docent)
- Recruiting
Department of Paediatrics, Vrinnevi Hospital
Norrköping, Region Östergötland, 603 79
Marie H. Lindgren, M.D., 46 10 103 00 00, Marie.H.Lindgren@regionostergotland.se
Maria Nordvall, M.D.
- Not yet recruiting
Department of Paediatrics
Örebro, Region Örebro County
Andreas Ohlin, M.D., +46 19 602 11 44, andreas.ohlin@oru.se
Andreas Ohlin, M.D.
- Not yet recruiting
Department of Paediatrics
Skövde, Västra Götalandsregionen
Carl-Johan Törnhage, M.D., +46 500-43 10 00, carl-johan.tornhage@vgregion.se
Carl-Johan Törnhage, M.D.
- Not yet recruiting
Department of Infectious Diseases
Uppsala, Region Uppsala
Elisabet Skoog, M.D., +46 18 611 00 00, elisabet.skoog@medsci.uu.se
Marie Edvinsson, M.D., Ph.D.
- Not yet recruiting
Department of Paediatrics
Uppsala, Region Uppsala
Josefin Årling, M.D., +46 18 611 00 00, josefin.arling@akademiska.se
Josefin Årling, M.D.
About this study
Official title: 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.
- Conditions
- Tick-Borne Diseases
- Keywords
- Clinical, Prospective, Multicenter, Observational, Longitudinal, Cohort
- Medical subject headings
- Tick-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
EuroQoL-5 Dimension Questionnaire (EQ-5D)
Difference in EQ-5D Health index between study inclusion and at the 6 month-follow-up
Measured: 6 months
Visual Analogue Scale for Health (VAS)
Difference between the VAS units at study inclusion and at 6 month-follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Sep 2023
- Primary completionDec 2030 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Tick-Borne DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- Region Östergötland, Region Kalmar County, Dalarna County Council, Sweden, FORSS - The Research Council of South-Eastern Sweden, ALF Grants, Region Östergötland, Linkoeping University, Region Uppsala Public Health and Care, Region Örebro County, Västra Götalandsregionen
- Responsible party
- Principal investigator, Anna J Henningsson, Region Jönköping County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781008
- Sponsor's protocol ID
- EPM 2022-05330-01
- Acronym
- SWEtick
- Status last verified
- Mar 2026
- First submitted
- 8 Jan 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication can be shared after anonymization, upon request
Publications
Henningsson AJ, Asgeirsson H, Hammas B, Karlsson E, Parke A, Hoornstra D, Wilhelmsson P, Hovius JW. Two Cases of Borrelia miyamotoi Meningitis, Sweden, 2018. Emerg Infect Dis. 2019 Oct;25(10):1965-1968. doi: 10.3201/eid2510.190416.
PubMed 31538916Uhnoo I, Cars O, Christensson D, Nystrom-Rosander C. First documented case of human babesiosis in Sweden. Scand J Infect Dis. 1992;24(4):541-7. doi: 10.3109/00365549209052642.
PubMed 1411322Eimer J, Fernstrom L, Rohlen L, Grankvist A, Loo K, Nyman E, Henningsson AJ, Haglund M, Hultqvist V, Sjowall J, Wenneras C, Schon T. Spiroplasma ixodetis Infections in Immunocompetent and Immunosuppressed Patients after Tick Exposure, Sweden. Emerg Infect Dis. 2022 Aug;28(8):1681-1685. doi: 10.3201/eid2808.212524.
PubMed 35876734Bjoersdorff A, Berglund J, Kristiansen BE, Soderstrom C, Eliasson I. [Varying clinical picture and course of human granulocytic ehrlichiosis. Twelve Scandinavian cases of the new tick-borne zoonosis are presented]. Lakartidningen. 1999 Sep 29;96(39):4200-4. Swedish.
PubMed 10544585Nilsson K, Elfving K, Pahlson C. Rickettsia helvetica in patient with meningitis, Sweden, 2006. Emerg Infect Dis. 2010 Mar;16(3):490-2. doi: 10.3201/eid1603.090184.
PubMed 20202426Nilsson K, Lindquist O, Pahlson C. Association of Rickettsia helvetica with chronic perimyocarditis in sudden cardiac death. Lancet. 1999 Oct 2;354(9185):1169-73. doi: 10.1016/S0140-6736(99)04093-3.
PubMed 10513711Wenneras C, Wass L, Bergstrom B, Grankvist A, Lingblom C. Ten years of detecting Neoehrlichia mikurensis infections in Sweden: demographic, clinical and inflammatory parameters. Eur J Clin Microbiol Infect Dis. 2024 Nov;43(11):2083-2092. doi: 10.1007/s10096-024-04909-5. Epub 2024 Aug 13.
PubMed 39136831Quarsten H, Henningsson A, Krogfelt KA, Strube C, Wenneras C, Mavin S. Tick-borne diseases under the radar in the North Sea Region. Ticks Tick Borne Dis. 2023 Jul;14(4):102185. doi: 10.1016/j.ttbdis.2023.102185. Epub 2023 Apr 26.
PubMed 37116420Henningsson AJ, Aase A, Bavelaar H, Flottorp S, Forsberg P, Kirkehei I, Lovmar M, Nilsson K, Nyman D, Ornstein K, Sjowall J, Skogman BH, Tjernberg I, Aaberge I. Laboratory Methods for Detection of Infectious Agents and Serological Response in Humans With Tick-Borne Infections: A Systematic Review of Evaluations Based on Clinical Patient Samples. Front Public Health. 2021 Sep 20;9:580102. doi: 10.3389/fpubh.2021.580102. eCollection 2021.
PubMed 34616701
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emerging Tick-borne Diseases in Children and Adults in Sweden (SWEtick): a Prospective Multicenter Study for Improved Patient Management
- ClinicalTrials.gov ID
- NCT06781008
- Acronym / sponsor ID
- SWEtick / EPM 2022-05330-01
- Conditions
- Tick-Borne Diseases
- Keywords
- Clinical, Prospective, Multicenter, Observational, Longitudinal, Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- Region Östergötland, Region Kalmar County, Dalarna County Council, Sweden, FORSS - The Research Council of South-Eastern Sweden, ALF Grants, Region Östergötland, Linkoeping University, Region Uppsala Public Health and Care, Region Örebro County, Västra Götalandsregionen
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical suspicion of tick-borne disease (physician's assessment based on medical history, symptoms, clinical findings and sometimes laboratory results)
Key exclusion criteria (1 listed)
- Incapacitated to understand the study information and make decisions (adults and adolescents >15 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Visual Analogue Scale for Health (VAS)
Time frame: 6 months
Difference between the VAS units at study inclusion and at 6 month-follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 31538916Henningsson AJ, Asgeirsson H, Hammas B, Karlsson E, Parke A, Hoornstra D, Wilhelmsson P, Hovius JW. Two Cases of Borrelia miyamotoi Meningitis, Sweden, 2018. Emerg Infect Dis. 2019 Oct;25(10):1965-1968. doi: 10.3201/eid2510.190416.
- Background: PubMed 1411322Uhnoo I, Cars O, Christensson D, Nystrom-Rosander C. First documented case of human babesiosis in Sweden. Scand J Infect Dis. 1992;24(4):541-7. doi: 10.3109/00365549209052642.
- Background: PubMed 35876734Eimer J, Fernstrom L, Rohlen L, Grankvist A, Loo K, Nyman E, Henningsson AJ, Haglund M, Hultqvist V, Sjowall J, Wenneras C, Schon T. Spiroplasma ixodetis Infections in Immunocompetent and Immunosuppressed Patients after Tick Exposure, Sweden. Emerg Infect Dis. 2022 Aug;28(8):1681-1685. doi: 10.3201/eid2808.212524.
- Background: PubMed 10544585Bjoersdorff A, Berglund J, Kristiansen BE, Soderstrom C, Eliasson I. [Varying clinical picture and course of human granulocytic ehrlichiosis. Twelve Scandinavian cases of the new tick-borne zoonosis are presented]. Lakartidningen. 1999 Sep 29;96(39):4200-4. Swedish.
- Background: PubMed 20202426Nilsson K, Elfving K, Pahlson C. Rickettsia helvetica in patient with meningitis, Sweden, 2006. Emerg Infect Dis. 2010 Mar;16(3):490-2. doi: 10.3201/eid1603.090184.
- Background: PubMed 10513711Nilsson K, Lindquist O, Pahlson C. Association of Rickettsia helvetica with chronic perimyocarditis in sudden cardiac death. Lancet. 1999 Oct 2;354(9185):1169-73. doi: 10.1016/S0140-6736(99)04093-3.
- Background: PubMed 39136831Wenneras C, Wass L, Bergstrom B, Grankvist A, Lingblom C. Ten years of detecting Neoehrlichia mikurensis infections in Sweden: demographic, clinical and inflammatory parameters. Eur J Clin Microbiol Infect Dis. 2024 Nov;43(11):2083-2092. doi: 10.1007/s10096-024-04909-5. Epub 2024 Aug 13.
- Background: PubMed 37116420Quarsten H, Henningsson A, Krogfelt KA, Strube C, Wenneras C, Mavin S. Tick-borne diseases under the radar in the North Sea Region. Ticks Tick Borne Dis. 2023 Jul;14(4):102185. doi: 10.1016/j.ttbdis.2023.102185. Epub 2023 Apr 26.
- Background: PubMed 34616701Henningsson AJ, Aase A, Bavelaar H, Flottorp S, Forsberg P, Kirkehei I, Lovmar M, Nilsson K, Nyman D, Ornstein K, Sjowall J, Skogman BH, Tjernberg I, Aaberge I. Laboratory Methods for Detection of Infectious Agents and Serological Response in Humans With Tick-Borne Infections: A Systematic Review of Evaluations Based on Clinical Patient Samples. Front Public Health. 2021 Sep 20;9:580102. doi: 10.3389/fpubh.2021.580102. eCollection 2021.
- General study information and contact detailsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication can be shared after anonymization, upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna J Henningsson, Senior Associate Professor contact
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tick-Borne Diseases, run by Region Jönköping County at 12 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna J Henningsson, Senior Associate Professor (46 10 242 12 26, anna.jonsson.henningsson@rjl.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQoL-5 Dimension Questionnaire (EQ-5D) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06781008, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.