Management of Tick-borne Encephalitis | NCT06593249

Studies
Management of Tick-borne Encephalitis

NCT06593249

Sponsor

University Medical Centre Ljubljana

Status

Completed

Last Update Posted

Dec 13, 2024Actual

Enrollment

318Actual

Phase

Not provided

Conditions

Infectious Encephalitis

Interventions

No Intervention: Observational Cohort

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2022Actual

Primary Completion Date

Sep 30, 2023Actual

Completion Date

Jun 30, 2024Actual

First Submitted Date

Sep 9, 2024

First Submission Date that Met QC Criteria

Sep 9, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2024

Last Update Posted Date

Dec 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

318Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No Intervention: Observational Cohort	Other	no intervention, observational study	TBE in Infectious Diseases Department TBE in Neurology Department

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
head imaging	Number (%) of patients with head imaging performed before proceeding to lumbar puncture.	at admission

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

microbiologically confirmed tick-borne meningoencephalitis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana, Ljublajana, Slovenia		Ljubljana			Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

On reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000069544	Infectious Encephalitis
D004675	Encephalitis, Tick-Borne

Ancestor Terms

ID	Term
D002494	Central Nervous System Infections
D007239	Infections
D004660	Encephalitis
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided