Study on Early Lyme Neuroborreliosis

Not Applicable

• Conditions: Nervous System Lyme Borreliosis
• Interventions: Drug: ceftriaxone

• Registration Number: NCT00910533
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-06-01
• Status Verified: 2017-05
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16
• Primary Completion: 2018-12-31
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old

Exclusion Criteria

• pregnancy
• lactation
• history of adverse reaction to a beta-lactam antibiotic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Lyme neuroborreliosis patients	ceftriaxone	-

Primary Outcome Measures

Name	Time	Method
Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis	1 year follow-up

Secondary Outcome Measures

Name	Time	Method
Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis	1 year follow-up

Trial Locations

Locations (1)

UMC Ljubljana, Department of Infectious Diseases; 🇸🇮 Ljubljana, Slovenia