Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00138801 |
Recruitment Status
:
Completed
First Posted
: August 30, 2005
Last Update Posted
: February 5, 2010
|
Sponsor:
Sorlandet Hospital HF
Information provided by:
Sorlandet Hospital HF
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 |
|
|||
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:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
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 |
|
|||
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 |