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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

August 29, 2005
August 30, 2005
February 5, 2010
March 2004
March 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00138801 on ClinicalTrials.gov Archive Site
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Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-blind Comparison
The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Lyme Neuroborreliosis
  • Drug: Ceftriaxone
  • Drug: Doxycycline
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Ljøstad U, Skogvoll E, Eikeland R, Midgard R, Skarpaas T, Berg A, Mygland A. Oral doxycycline versus intravenous ceftriaxone for European Lyme neuroborreliosis: a multicentre, non-inferiority, double-blind, randomised trial. Lancet Neurol. 2008 Aug;7(8):690-5. doi: 10.1016/S1474-4422(08)70119-4. Epub 2008 Jun 21. Erratum in: Lancet Neurol. 2008 Aug;7(8):675.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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December 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Svein Gunnar Gundersen, Sorlandet hospital HF
Sorlandet Hospital HF
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Study Chair: Åse Mygland, MD, PhD Sorlandet Sykehus HF
Sorlandet Hospital HF
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP