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Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

This study has been completed.
Sponsor:
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00138801
First received: August 29, 2005
Last updated: February 4, 2010
Last verified: March 2005
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Sorlandet Hospital HF

Additional 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
Study First Received: August 29, 2005
Last Updated: February 4, 2010
Health Authority: Norway: Directorate of Health

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
 Ceftriaxone
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 23, 2013