Fever After Tick Bite Study

NCT ID: NCT03932448

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2025-04-04

Brief Summary

The proposed study is a collaboration between Microbiology, SU/Sahlgrenska and the Infectious Diseases clinic at SU/Östra as well as several Infectious Diseases clinics throughout Sweden aiming at improving microbiological diagnostic assays regarding the early identification of tick-borne microorganisms (including as of yet unidentified pathogens) capable of causing human disease using modern diagnostic tools.

At the initial study visit (day 0) plasma, serum, urine, saliva, and PBMCs (and tick, if available) will be collected from patients developing fever within two weeks after a tick bite. Additional follow-up samples will be obtained after 9 and 30 days as well as after 6 months. The initial samples will be analyzed using (a) directed multiplex PCR analysis for Tick-Borne Encephalitis (TBE), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella, Tularemia, and Babesiosis in plasma, whole blood and urine, (b) conventional IgM and IgG serology for TBE, (c) "Next Generation Sequencing" (NGS) for the detection of bacterial 16s rRNA as well as unknown viruses, (d) potential biomarkers, and (e) host genetic factors. Among patients where initial sampling indicates the presence of a potential pathogen or in patients developing neurological symptoms, a lumbar puncture will be performed and CSF will be further analyzed. Samples will also be evaluated regarding potential microbiological factors predisposing for severity of infection.

The primary objective of the study is to improve diagnostic tools in the initial early phase of infections caused by tick-borne pathogens, especially TBE prior to the affliction of the central nervous system, and to attempt to identify which factors impact the course of infection as it is believed that approximately 75% of infected individuals resolve their infection in this first phase whereas others develop meningoencephalitis with significant subsequent neurological sequelae. Secondary objectives of the study include investigating for the presence of and treating other tick-borne pathogens, setting the stage for coming clinical trials evaluating novel anti-viral therapies for TBE.

Conditions

Tick-Bite; Fever; Tick Fever; Tick-Borne Diseases; Encephalitis, Tick-Borne; Tick Bites

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

The proposed study is not interventional.

The proposed study is not interventional. However, if a treatable microorganism is detected, e.g. Borrelia or Anaplasma, suitable therapy, e.g. doxycycline, will be in initiated if appropriate.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Male and female patients ≥18 years of age
• Medical history of tick bite within past 2 weeks
• Documented or medical history of fever (≥38°C) within past 2 weeks

Exclusion Criteria

• Inability or unwillingness to provide informed consent or abide by the requirements of the study
• Presence of urinary tract symptoms
• Presence of non-tick related, infectious agent causing fever, e.g. a respiratory virus
• Presence of other medical, non-infectious cause of fever

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Lagging, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

Dept. of Infectious Diseases

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

FATB Study Group

Identifier Type: -

Identifier Source: org_study_id