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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014