ClinicalTrials.gov
ClinicalTrials.gov Menu

Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00942006
Recruitment Status : Unknown
Verified July 2009 by University Medical Centre Ljubljana.
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2009
Last Update Posted : July 20, 2009
Sponsor:
Information provided by:
University Medical Centre Ljubljana

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.

Condition or disease Intervention/treatment Phase
Suspected Early Lyme Neuroborreliosis Drug: doxycycline Drug: ceftriaxone Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.
Study Start Date : July 2009
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: LNB-doxycycline Drug: doxycycline
100 mg bid, 14 days
Active Comparator: LNB-ceftriaxone Drug: ceftriaxone
2g x 1 iv, 14 days


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days. [ Time Frame: 1 year follow-up ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >15 years
  • erythema migrans in 4 months period before neurologic symptoms
  • normal CSF cell count
  • absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).

Exclusion Criteria:

  • pregnancy
  • lactation
  • allergy on doxycycline and ceftriaxone
  • immune deficiency.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00942006


Contacts
Contact: Katarina Ogrinc, MD PhD +386 1 522 4217 katarina.ogrinc1@guest.arnes.si
Contact: Franc Strle, PhD MD +386 1 522 2110 franc.strle@kclj.si

Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Franc Strle, MD PhD UMC Ljubljana
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Katarina Ogrinc MD PhD, UMC Ljubljana
ClinicalTrials.gov Identifier: NCT00942006     History of Changes
Other Study ID Numbers: LNB-doxy-ceftriaxone
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: July 20, 2009
Last Verified: July 2009

Keywords provided by University Medical Centre Ljubljana:
Lyme neuroborreliosis
Lyme borreliosis
erythema migrans
doxycycline treatment
 ceftriaxone treatment
outcome
subjective symptoms

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