Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis According to Diagnostic Certainty

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.

Study Overview

• Status: Completed
• Conditions: Lyme Disease

• Study Type: Observational
• Enrollment (Actual): 311

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia
    • University Medical Center Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with definite or possible early Lyme neuroborreliosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
definite LNB; patients with definite early Lyme neuroborreliosis
possible LNB; patients with possible early Lyme neuroborreliosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2008
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: November 28, 2020
• First Posted (ACTUAL): December 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: antibiotic therapy; Lyme neuroborreliosis; post-Lyme borreliosis symptoms
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Tick-Borne Diseases; Borrelia Infections; Spirochaetales Infections; Lyme Disease; Lyme Neuroborreliosis
• Other Study ID Numbers: LNB-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No