Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis - Tabular View

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

December 14, 2005

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00138801 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

Official Title ^ICMJE

Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-Blind Comparison

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Lyme Neuroborreliosis

Intervention ^ICMJE

Drug: Ceftriaxone
Drug: Doxycycline

Study Arms / Comparison Groups

Publications *

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. Epub 2008 Jun 21.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Unn Ljøstad, MD

++4738073910

unn.ljostad@sshf.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00138801

Responsible Party

Study ID Numbers ^ICMJE

SSHF70204

Study Sponsor ^ICMJE

Sorlandet Hospital HF

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Åse Mygland, MD, PhD

Sorlandet Sykehus HF

Information Provided By

Sorlandet Hospital HF

Verification Date

March 2005

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