NCT06593249

Brief Summary

In this retrospective cohort study of patients with tick-borne encephalitis (TBE), potential differences in the clinical presentation at admission and diagnostic and therapeutic management of patients with TBE initially referred to infectious diseases or neurology departments were assessed. Associations between severity of acute illness and clinical outcome were also explored.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

December 13, 2024

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

September 9, 2024

Last Update Submit

December 9, 2024

Conditions

Keywords

tick-borne encephalitisoutcomeneuroimaginglumbar punctureclinical management

Outcome Measures

Primary Outcomes (1)

  • head imaging

    Number (%) of patients with head imaging performed before proceeding to lumbar puncture.

    at admission

Study Arms (2)

TBE in Infectious Diseases Department

patients with TBE referred to ID

Other: No Intervention: Observational Cohort

TBE in Neurology Department

Patients with TBE in Neurology Department

Other: No Intervention: Observational Cohort

Interventions

no intervention, observational study

TBE in Infectious Diseases DepartmentTBE in Neurology Department

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with tick-borne encepalitis referred to Infectious diseases or Neurology departments of the University Medical Centre Ljubljana, Slovenia during the COVID-19 pandemic (from March 2020 to September 2022).

You may qualify if:

  • microbiologically confirmed tick-borne meningoencephalitis

You may not qualify if:

  • Exchanged between ID and neurology within the first 48 hours due to organizational constraints
  • Transferred from another hospital
  • Lumbar puncture not performed
  • Not fulfilling study criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana, Ljublajana, Slovenia

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Infectious EncephalitisEncephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Central Nervous System InfectionsInfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesEncephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

September 30, 2022

Primary Completion

September 30, 2023

Study Completion

June 30, 2024

Last Updated

December 13, 2024

Record last verified: 2020-03

Locations