Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04653558

Enrollment

311

Registered

2020-12-04

Start date

2008-01-01

Completion date

2020-06-30

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme Disease

Keywords

Lyme neuroborreliosis, post-Lyme borreliosis symptoms, antibiotic therapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Slovenia

Outcome results