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Study on Early Lyme Neuroborreliosis

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ClinicalTrials.gov Identifier: NCT00910533
Recruitment Status : Recruiting
First Posted : June 1, 2009
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Nervous System Lyme Borreliosis Drug: ceftriaxone

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis
Study Start Date : June 2009
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis [ Time Frame: 1 year follow-up ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00910533     History of Changes
Other Study ID Numbers: LNB-0509
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Franc Strle, University Medical Centre Ljubljana:
Lyme neuroborreliosis

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