Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

NCT04653558 | Completed

• 1 other identifier: LNB-2020
• Study Type: observational
• Target: 311
• Locations: 1 country
• Sites: 1

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.

Conditions

Lyme Disease

Keywords

Lyme neuroborreliosis; post-Lyme borreliosis symptoms; antibiotic therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

definite LNB

patients with definite early Lyme neuroborreliosis

possible LNB

patients with possible early Lyme neuroborreliosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with definite or possible early Lyme neuroborreliosis

You may qualify if:

• early Lyme neuroborreliosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical center Ljubljana

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Lyme Disease; Lyme Neuroborreliosis

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2020
• First Posted: December 4, 2020
• Study Start: January 1, 2008
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

SL (1)