Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

This study has been completed.

First Received: August 29, 2005 Last Updated: February 4, 2010 History of Changes

Sponsor:	Sorlandet Hospital HF
Information provided by:	Sorlandet Hospital HF
ClinicalTrials.gov Identifier:	NCT00138801

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 III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-blind Comparison

Resource links provided by NLM:

Drug Information available for: Doxycycline Doxycycline hyclate Ceftriaxone Ceftriaxone Sodium Doxycycline calcium

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, Vest-Agder
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 National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Sorlandet hospital HF ( Svein Gunnar Gundersen )
Study ID Numbers:	SSHF813204
Study First Received:	August 29, 2005
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00138801 History of Changes
Health Authority:	Norway: Directorate for Health and Social Affairs

Keywords provided by Sorlandet Hospital HF:

Neuroborreliosis

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Antiprotozoal Agents
Borrelia Infections
Lyme Disease
Nervous System Diseases
Central Nervous System Diseases
Ceftriaxone
Pharmacologic Actions
Tick-Borne Diseases

Gram-Negative Bacterial Infections
Antimalarials
Anti-Bacterial Agents
Antiparasitic Agents
Central Nervous System Infections
Spirochaetales Infections
Therapeutic Uses
Central Nervous System Bacterial Infections
Lyme Neuroborreliosis
Doxycycline

ClinicalTrials.gov processed this record on February 04, 2010