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 Locations

  • Slovenia
      • 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
Drug: ceftriaxone
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.

Sponsor

University Medical Centre Ljubljana

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

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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