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Study on Early Lyme Neuroborreliosis

This study is currently recruiting participants.
Verified June 2012 by University Medical Centre Ljubljana
Sponsor:
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00910533
First received: May 28, 2009
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention
Nervous System Lyme Borreliosis
 Drug: ceftriaxone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

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 [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910533

Contacts
Contact: Dasa Stupica, MD +38615222110 cerar.dasa@gmail.com
Contact: Franc Strle, MD +38615222110 franc.strle@kclj.si

Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases Recruiting
Ljubljana, Slovenia, 1525
Contact: Dasa Stupica, MD     +386 1 522 2110     cerar.dasa@gmail.com    
Contact: Franc Strle, MD     +386 1 5222610     franc.strle@kclj.si    
Principal Investigator: Dasa Stupica, M.D., PhD            
Sub-Investigator: Katarina Ogrinc, M.D., PhD            
Sub-Investigator: Petra Bogovic, MD            
Sub-Investigator: Eva Ruzic-Sabljic, M.D., PhD            
Sub-Investigator: Tjasa Cerar, PhD            
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Franc Strle, MD UMC Ljubljana
  More Information

No publications provided

Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00910533     History of Changes
Other Study ID Numbers: LNB-0509
Study First Received: May 28, 2009
Last Updated: June 13, 2012
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
Lyme neuroborreliosis

Additional relevant MeSH terms:
Tick-Borne Diseases
Borrelia Infections
Lyme Disease
Lyme Neuroborreliosis
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Central Nervous System Bacterial Infections
 Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013