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Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

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ClinicalTrials.gov Identifier: NCT00138801
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : February 5, 2010
Information provided by:
Sorlandet Hospital HF

Brief Summary:
The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.

Condition or disease Intervention/treatment Phase
Lyme Neuroborreliosis Drug: Ceftriaxone Drug: Doxycycline Phase 3

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : March 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : December 2008

Information from the National Library of Medicine

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

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

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

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Sørlandet Sykehus HF
Kristiansand, Vest-Agder, Norway, 4633
Sponsors and Collaborators
Sorlandet Hospital HF
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Study Chair: Åse Mygland, MD, PhD Sorlandet Sykehus HF
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Svein Gunnar Gundersen, Sorlandet hospital HF
ClinicalTrials.gov Identifier: NCT00138801    
Other Study ID Numbers: SSHF813204
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: February 5, 2010
Last Verified: March 2005
Keywords provided by Sorlandet Hospital HF:
Additional relevant MeSH terms:
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Lyme Neuroborreliosis
Central Nervous System Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Lyme Disease
Gram-Negative Bacterial Infections
Borrelia Infections
Spirochaetales Infections
Central Nervous System Infections
Tick-Borne Diseases
Vector Borne Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents