Back to resultsEffect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
Primary Purpose
Lyme Neuroborreliosis
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Ceftriaxone
Doxycycline
Sponsored by
About this trial
This is an interventional diagnostic trial for Lyme Neuroborreliosis focused on measuring Neuroborreliosis
Eligibility 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
Sites / Locations
- Sørlandet Sykehus HF
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Doxycycline
cephtriaxone
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00138801
Brief Title
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
Official Title
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-blind Comparison
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Neuroborreliosis
Keywords
Neuroborreliosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Doxycycline
Arm Title
2
Arm Type
Active Comparator
Arm Description
cephtriaxone
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Type
Drug
Intervention Name(s)
Doxycycline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Åse Mygland, MD, PhD
Organizational Affiliation
Sorlandet Sykehus HF
Official's Role
Study Chair
Facility Information:
Facility Name
Sørlandet Sykehus HF
City
Kristiansand
State/Province
Vest-Agder
ZIP/Postal Code
4633
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
18567539
Citation
Ljostad 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.
Results Reference
derived
Learn more about this trial
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
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