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
About this trial
This is an interventional other trial for Nervous System Lyme Borreliosis focused on measuring Lyme neuroborreliosis
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
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
NCT ID
NCT00910533
First Posted
May 28, 2009
Last Updated
October 15, 2018
Sponsor
University Medical Centre Ljubljana
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
Learn more about this trial
Study on Early Lyme Neuroborreliosis
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