Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

Lyme Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653558
• Other study ID #: LNB-2020
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2020
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lyme Disease
• Lyme Neuroborreliosis

Locations

Country	Name	City	State
Slovenia	University Medical center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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