Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

This study is currently recruiting participants.

Verified by Sorlandet Hospital HF, March 2005

Sponsored by:	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

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-Blind Comparison

Further study details as provided by Sorlandet Hospital HF:

Study Start Date:

March 2004

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

Contacts

Contact: Unn Ljøstad, MD

++4738073910

unn.ljostad@sshf.no

Locations

Norway, Vest-Agder
Sørlandet Sykehus HF	Recruiting
Kristiansand, Vest-Agder, Norway, 4633
Contact: Svein Gunnar Gundersen, MD, PhD ++4738073000 s.g.gundersen@sshf.no
Principal Investigator: Unn Ljøstad, MD

Sponsors and Collaborators

Sorlandet Hospital HF

Investigators

Study Chair:

Åse Mygland, MD, PhD

Sorlandet Sykehus HF

More Information

Publications indexed to this study:

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.

Study ID Numbers:	SSHF70204
Study First Received:	August 29, 2005
Last Updated:	December 14, 2005
ClinicalTrials.gov Identifier:	NCT00138801
Health Authority:	Norway: Directorate for Health and Social Affairs

Keywords provided by Sorlandet Hospital HF:

Neuroborreliosis

Study placed in the following topic categories:

Bacterial Infections
Central Nervous System Infections
Borrelia Infections
Borreliosis
Lyme Disease
Central Nervous System Diseases

Lyme Neuroborreliosis
Ceftriaxone
Doxycycline
Tick-Borne Diseases
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Antimalarials
Anti-Infective Agents
Anti-Bacterial Agents
Antiparasitic Agents
Antiprotozoal Agents

Spirochaetales Infections
Therapeutic Uses
Nervous System Diseases
Central Nervous System Bacterial Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009