Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

May 3, 2023 updated by: Sorlandet Hospital HF

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Vest-Agder
      • Kristiansand, Vest-Agder, Norway, 4633
        • Sørlandet Sykehus HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Doxycycline
Drug: Doxycycline
Active Comparator: 2
cephtriaxone
Drug: Ceftriaxone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorlandet Hospital HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

March 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSHF813204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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