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Study on Early Lyme Neuroborreliosis

Primary Purpose

Nervous System Lyme Borreliosis

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
ceftriaxone
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nervous System Lyme Borreliosis focused on measuring Lyme neuroborreliosis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UMC Ljubljana, Department of Infectious DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Early Lyme neuroborreliosis patients

control subjects

Arm Description

Control subjects without a history of Lyme borreliosis.

Outcomes

Primary Outcome Measures

Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis

Secondary Outcome Measures

Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis

Full Information

First Posted
May 28, 2009
Last Updated
October 15, 2018
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT00910533
Brief Title
Study on Early Lyme Neuroborreliosis
Official Title
Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2009 (undefined)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nervous System Lyme Borreliosis
Keywords
Lyme neuroborreliosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Lyme neuroborreliosis patients
Arm Type
Active Comparator
Arm Title
control subjects
Arm Type
No Intervention
Arm Description
Control subjects without a history of Lyme borreliosis.
Intervention Type
Drug
Intervention Name(s)
ceftriaxone
Intervention Description
ceftriaxone 2 g od i.v. for 14 days
Primary Outcome Measure Information:
Title
Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis
Time Frame
1 year follow-up
Secondary Outcome Measure Information:
Title
Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis
Time Frame
1 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dasa Stupica, MD
Phone
+38615222110
Email
cerar.dasa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Franc Strle, MD
Phone
+38615222110
Email
franc.strle@kclj.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD
Organizational Affiliation
UMC Ljubljana
Official's Role
Study Chair
Facility Information:
Facility Name
UMC Ljubljana, Department of Infectious Diseases
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dasa Stupica, MD
Phone
+386 1 522 2110
Email
cerar.dasa@gmail.com
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD
Phone
+386 1 5222610
Email
franc.strle@kclj.si
First Name & Middle Initial & Last Name & Degree
Dasa Stupica, M.D., PhD
First Name & Middle Initial & Last Name & Degree
Katarina Ogrinc, M.D., PhD
First Name & Middle Initial & Last Name & Degree
Petra Bogovic, MD
First Name & Middle Initial & Last Name & Degree
Eva Ruzic-Sabljic, M.D., PhD
First Name & Middle Initial & Last Name & Degree
Tjasa Cerar, PhD

12. IPD Sharing Statement

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Study on Early Lyme Neuroborreliosis

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