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OpenTrials
Completed

NCT Number: NCT04653558

Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical center Ljubljana

Ljubljana, Slovenia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. composite clinical score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2017
Study completion
2020
First posted
Dec 4, 2020
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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