Clinical trial NCT06781008: SWEtick - a Prospective Multicenter Study of Tick-borne Diseases in Sweden
Official title: Emerging Tick-borne Diseases in Children and Adults in Sweden (SWEtick): a Prospective Multicenter Study for Improved Patient Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tick-Borne Diseases
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: Region Östergötland
name: Region Kalmar County
name: Region Dalarna
name: FORSS - The Research Council of South-Eastern Sweden
name: ALF Grants, Region Östergötland
name: Linkoeping University
First posted: 2025-01-17
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: EuroQoL-5 Dimension Questionnaire (EQ-5D)
timeFrame: 6 months
measure: Visual Analogue Scale for Health (VAS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eksjö
country: Sweden
facility: Department of Paediatrics, Eksjö Hospital
state: Region Jönköping County
city: Jönköping
country: Sweden
facility: Department of Infectious Diseases, County Hospital Ryhov
state: Region Jönköping County
city: Kalmar
country: Sweden
facility: Department of Infectious Diseases, Kalmar County Hospital
state: Region Kalmar County
city: Linköping
country: Sweden
facility: Department of Infectious Diseases, Linköping University Hospital
state: Region Östergötland
city: Norrköping
country: Sweden
facility: Department of Infectious Diseases, Vrinnevi Hospital
state: Region Östergötland
city: Norrköping
country: Sweden
facility: Department of Paediatrics, Vrinnevi Hospital
state: Region Östergötland
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.