Study on Early Lyme Neuroborreliosis

This study is currently recruiting participants.
Verified June 2013 by University Medical Centre Ljubljana
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana Identifier:
First received: May 28, 2009
Last updated: June 23, 2013
Last verified: June 2013

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:

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 2014 (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.


Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00910533

Contact: Dasa Stupica, MD +38615222110
Contact: Franc Strle, MD +38615222110

UMC Ljubljana, Department of Infectious Diseases Recruiting
Ljubljana, Slovenia, 1525
Contact: Dasa Stupica, MD    +386 1 522 2110   
Contact: Franc Strle, MD    +386 1 5222610   
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
Study Chair: Franc Strle, MD UMC Ljubljana
  More Information

No publications provided

Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana Identifier: NCT00910533     History of Changes
Other Study ID Numbers: LNB-0509
Study First Received: May 28, 2009
Last Updated: June 23, 2013
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
Lyme neuroborreliosis

Additional relevant MeSH terms:
Borrelia Infections
Lyme Disease
Lyme Neuroborreliosis
Tick-Borne Diseases
Central Nervous System Diseases
Nervous System Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Central Nervous System Bacterial Infections
Central Nervous System Infections
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014