Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

NCT ID: NCT04653558

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

311 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Lyme Disease

Keywords

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Lyme neuroborreliosis post-Lyme borreliosis symptoms antibiotic therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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definite LNB

patients with definite early Lyme neuroborreliosis

No interventions assigned to this group

possible LNB

patients with possible early Lyme neuroborreliosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Daša Stupica

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical center Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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LNB-2020

Identifier Type: -

Identifier Source: org_study_id