Clincosm LogoSign in Get a demo

Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

Sponsor
Sorlandet Hospital HF (Other)
Overall Status
Completed
CT.gov ID
NCT00138801
Collaborator
(none)
1
Location
57
Duration (Months)

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Mar 1, 2004
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sørlandet Sykehus HF Kristiansand Vest-Agder Norway 4633

    Sponsors and Collaborators

    • Sorlandet Hospital HF

    Investigators

    • Study Chair: Åse Mygland, MD, PhD, Sorlandet Sykehus HF

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00138801
    Other Study ID Numbers:
    • SSHF813204
    First Posted:
    Aug 30, 2005
    Last Update Posted:
    Feb 5, 2010
    Last Verified:
    Mar 1, 2005
    Keywords provided by , ,
    Neuroborreliosis
    Additional relevant MeSH terms:
    Lyme Neuroborreliosis
    Doxycycline
    Ceftriaxone

    Study Results

    No Results Posted as of Feb 5, 2010