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Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by University Medical Centre Ljubljana.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942006
First Posted: July 20, 2009
Last Update Posted: July 20, 2009
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.
Information provided by:
University Medical Centre Ljubljana
  Purpose
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 Intervention
Suspected Early Lyme Neuroborreliosis Drug: doxycycline Drug: ceftriaxone

Study Type: Interventional
Study Design: 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.

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 for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days. [ Time Frame: 1 year follow-up ]

Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LNB-doxycycline Drug: doxycycline
100 mg bid, 14 days
Active Comparator: LNB-ceftriaxone Drug: ceftriaxone
2g x 1 iv, 14 days

  Eligibility

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:   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
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

Responsible Party: Katarina Ogrinc MD PhD, UMC Ljubljana
ClinicalTrials.gov Identifier: NCT00942006     History of Changes
Other Study ID Numbers: LNB-doxy-ceftriaxone
First Submitted: July 17, 2009
First Posted: July 20, 2009
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
Central Nervous System Bacterial Infections
Bacterial Infections
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Doxycycline
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents