Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

Tracking Information
First Submitted Date ICMJE	August 29, 2005
First Posted Date ICMJE	August 30, 2005
Last Update Posted Date	February 5, 2010
Study Start Date ICMJE	March 2004
Actual Primary Completion Date	March 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00138801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
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	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic
Condition ICMJE	Lyme Neuroborreliosis
Intervention ICMJE	Drug: Ceftriaxone; Drug: Doxycycline
Study Arms	Not Provided
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. doi: 10.1016/S1474-4422(08)70119-4. Epub 2008 Jun 21. Erratum in: Lancet Neurol. 2008 Aug;7(8):675.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	December 2008
Actual Primary Completion Date	March 2008 (Final data collection date for primary outcome measure)
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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Norway
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00138801
Other Study ID Numbers ICMJE	SSHF813204
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Svein Gunnar Gundersen, Sorlandet hospital HF
Study Sponsor ICMJE	Sorlandet Hospital HF
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Åse Mygland, MD, PhD Sorlandet Sykehus HF
PRS Account	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