Clinical Manifestations and Long-Term Outcome in Early Ly... | NCT04653558

Studies
Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

NCT04653558

Sponsor

University Medical Centre Ljubljana

Status

Completed

Last Update Posted

Dec 7, 2020Actual

Enrollment

311Actual

Phase

Not provided

Conditions

Lyme Disease

Interventions

Not provided

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

Dec 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

Jan 1, 2008Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Nov 28, 2020

First Submission Date that Met QC Criteria

Nov 28, 2020

First Posted Date

Dec 4, 2020Actual

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 3, 2020

Last Update Posted Date

Dec 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daša Stupica, Principal Investigator, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

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 early Lyme neuroborreliosis (LNB), clinical and microbiologic characteristics and long-term outcome of definite vs. possible LNB were evaluated at a single university medical center in Slovenia. Severity of acute disease and long-term outcome during a 12-month follow-up were assessed using a composite clinical score based on objective clinical findings and subjective complaints.

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

311Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
definite LNB		patients with definite early Lyme neuroborreliosis
possible LNB		patients with possible early Lyme neuroborreliosis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
composite clinical score	Composite clinical score based on objective clinical findings and subjective complaints. The sum of subjective complaints and objective findings scored as 0=absent or 1=present represent severity of disease on admission or clinical outcome at follow-up, respectively. Maximum total score=31	follow-up for 12 months-post-treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

early Lyme neuroborreliosis

Exclusion Criteria:

Not fulfilling study criteria for definite or possible Lyme neuroborreliosis
Alternative diagnosis during follow-up
Concomitant tick-borne encephalitis
Clinical symptoms/signs present for >6 months
Data not available

Accepts Healthy Volunteers

Not provided

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 definite or possible early Lyme neuroborreliosis

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 center Ljubljana		Ljubljana			Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Only on reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008193	Lyme Disease
D020852	Lyme Neuroborreliosis

Ancestor Terms

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided