Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

This study has been completed.

First Received on August 29, 2005. Last Updated on 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:	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:

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
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):

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:	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 for Health and Social Affairs

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 February 12, 2012