- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00910533
Study on Early Lyme Neuroborreliosis
October 15, 2018 updated by: Franc Strle, University Medical Centre Ljubljana
Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis
The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dasa Stupica, MD
- Phone Number: +38615222110
- Email: cerar.dasa@gmail.com
Study Contact Backup
- Name: Franc Strle, MD
- Phone Number: +38615222110
- Email: franc.strle@kclj.si
Study Locations
-
-
-
Ljubljana, Slovenia, 1525
- Recruiting
- UMC Ljubljana, Department of Infectious Diseases
-
Principal Investigator:
- Dasa Stupica, M.D., PhD
-
Sub-Investigator:
- Katarina Ogrinc, M.D., PhD
-
Sub-Investigator:
- Eva Ruzic-Sabljic, M.D., PhD
-
Sub-Investigator:
- Tjasa Cerar, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Early Lyme neuroborreliosis patients
|
ceftriaxone 2 g od i.v. for 14 days
|
No Intervention: control subjects
Control subjects without a history of Lyme borreliosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis
Time Frame: 1 year follow-up
|
1 year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Anticipated)
December 31, 2018
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
May 28, 2009
First Submitted That Met QC Criteria
May 28, 2009
First Posted (Estimate)
June 1, 2009
Study Record Updates
Last Update Posted (Actual)
October 16, 2018
Last Update Submitted That Met QC Criteria
October 15, 2018
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Central Nervous System Infections
- Vector Borne Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Central Nervous System Bacterial Infections
- Tick-Borne Diseases
- Borrelia Infections
- Spirochaetales Infections
- Lyme Disease
- Lyme Neuroborreliosis
- Anti-Infective Agents
- Anti-Bacterial Agents
- Ceftriaxone
Other Study ID Numbers
- LNB-0509
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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