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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04653558
Other study ID # LNB-2020
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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