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

NCT06781008 | Recruiting

• 1 other identifier: EPM 2022-05330-01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 12

Brief 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 patients with suspected eTBD within the Swedish healthcare system.

Conditions

Tick-Borne Diseases

Keywords

Clinical; Prospective; Multicenter; Observational; Longitudinal; Cohort

Outcome Measures

Primary Outcomes (2)

• EuroQoL-5 Dimension Questionnaire (EQ-5D)

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

  6 months

• Visual Analogue Scale for Health (VAS)

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

  6 months

Study Arms (5)

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

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Jönköping County: lead
• Region of Uppsala: collaborator
• Region Örebro County: collaborator
• Västra Götalandsregionen: collaborator
• 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

Study Sites (12)

Department of Paediatrics

Falun, Region Dalarna, Sweden

RECRUITING

Department of Paediatrics, Eksjö Hospital

Eksjö, Region Jönköping County, 575 81, Sweden

RECRUITING

Department of Infectious Diseases, County Hospital Ryhov

Jönköping, Region Jönköping County, 55185, Sweden

RECRUITING

Department of Paediatrics

Jönköping, Region Jönköping County, 55185, Sweden

RECRUITING

Department of Infectious Diseases, Kalmar County Hospital

Kalmar, Region Kalmar County, 392 56, Sweden

RECRUITING

Department of Infectious Diseases

Uppsala, Region Uppsala, Sweden

NOT YET RECRUITING

Department of Paediatrics

Uppsala, Region Uppsala, Sweden

NOT YET RECRUITING

Department of Paediatrics

Örebro, Region Örebro County, Sweden

NOT YET RECRUITING

Department of Infectious Diseases, Linköping University Hospital

Linköping, Region Östergötland, 581 85, Sweden

RECRUITING

Department of Infectious Diseases, Vrinnevi Hospital

Norrköping, Region Östergötland, 603 79, Sweden

RECRUITING

Department of Paediatrics, Vrinnevi Hospital

Norrköping, Region Östergötland, 603 79, Sweden

RECRUITING

Department of Paediatrics

Skövde, Västra Götalandsregionen, Sweden

NOT YET RECRUITING

Related Publications (9)

• 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.

  PMID: 31538916 BACKGROUND

• Uhnoo 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.

  PMID: 1411322 BACKGROUND

• Eimer 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.

  PMID: 35876734 BACKGROUND

• Bjoersdorff 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.

  PMID: 10544585 BACKGROUND

• Nilsson 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.

  PMID: 20202426 BACKGROUND

• Nilsson 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.

  PMID: 10513711 BACKGROUND

• Wenneras 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.

  PMID: 39136831 BACKGROUND

• Quarsten 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.

  PMID: 37116420 BACKGROUND

• Henningsson 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.

  PMID: 34616701 BACKGROUND

Related Links

• General study information and contact details

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, skin biopsies, cerebrospinal fluid, synovial fluid

MeSH Terms

Conditions

Tick-Borne Diseases

Condition Hierarchy (Ancestors)

Vector Borne Diseases; Infections

Central Study Contacts

Anna J Henningsson, Senior Associate Professor

CONTACT

46 10 242 12 26; anna.jonsson.henningsson@rjl.se

Johanna Sjöwall, Associate Professor (docent)

CONTACT

46 10 104 08 94; johanna.sjowall@liu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Senior Associate Professor

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 17, 2025
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

SE (12)