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Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00138801
First Posted: August 30, 2005
Last Update Posted: February 5, 2010
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:
Sorlandet Hospital HF
  Purpose
The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.

Condition Intervention Phase
Lyme Neuroborreliosis Drug: Ceftriaxone Drug: Doxycycline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-blind Comparison

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Study Start Date: March 2004
Study Completion Date: December 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled:

    • Intrathecal production of borrelia antibodies;
    • White cell count in cerebrospinal fluid (CSF) > 5/mm3;
    • Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval;
    • Verified acrodermatitis chronica atrophicans.

Exclusion Criteria:

  • Allergy to the contents in the medication, or earlier type I reaction to penicillin.
  • Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days
  • Pregnancy or breastfeeding
  • Age < 18 years
  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): NCT00138801


Locations
Norway
Sørlandet Sykehus HF
Kristiansand, Vest-Agder, Norway, 4633
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Study Chair: Åse Mygland, MD, PhD Sorlandet Sykehus HF
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Svein Gunnar Gundersen, Sorlandet hospital HF
ClinicalTrials.gov Identifier: NCT00138801     History of Changes
Other Study ID Numbers: SSHF813204
First Submitted: August 29, 2005
First Posted: August 30, 2005
Last Update Posted: February 5, 2010
Last Verified: March 2005

Keywords provided by Sorlandet Hospital HF:
Neuroborreliosis

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