Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

Completed

• Conditions: Lyme Disease

• Registration Number: NCT04653558
• Lead Sponsor: University Medical Centre Ljubljana

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 available

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2020-06-30
• Study First Submitted: 2020-11-28
• Study First Submitted QC: 2020-11-28
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite clinical score	follow-up for 12 months-post-treatment	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

Trial Locations

Locations (1)

University Medical center Ljubljana; 🇸🇮 Ljubljana, Slovenia