Study of Lyme Neuroborreliosis
Primary Purpose
Lyme Neuroborreliosis
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Doxycycline
Ceftriaxone
Sponsored by
About this trial
This is an interventional treatment trial for Lyme Neuroborreliosis focused on measuring doxycycline, ceftriaxone
Eligibility Criteria
Inclusion Criteria for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled):
- Neurological symptoms suggestive of LNB without other obvious reasons
- CSF pleocytosis (>4 leukocytes per mikrol)
- Intrathecal production of B. burgdorferi specific antibodies
- Detection of B. burgdorferi DNA in central spinal fluid
Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled):
- Neurological symptoms suggestive of LNB wihtout other obvious reasons
- Production of B. burgdorferi spesific antibodies in serum
- Erythema migrans during the previous three months
Exclusion Criteria:
- pregnancy and breastfeeding
- women planning to get pregnant in two months
- age under 18
- handicapped persons
- prisoners
- use of any antibiotics two weeks before study treatments begins
- allergy for tetracyclines or cephalosporins
Sites / Locations
- Helsinki University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ceftriaxone
Doxycycline
Arm Description
Treatment of intravenous ceftriaxone (2 g/day), three weeks
Treatment with oral doxycycline (200mg / day), four weeks
Outcomes
Primary Outcome Measures
The improvement of the clinical condition during the study.
The clinical condition of participants will be evaluated with visual analogue scale (from 0 to 10, 0=best) by the participants. The VAS scores are collected before the treatment with antibiotics, and 4 months and 12 months after the treatment.
The clinical condition evaluated by the participants after 12 months from the treatment
The clinical condition is evaluated with VAS by the participants.
Secondary Outcome Measures
Central spinal fluid (CSF) pleocytosis
The decline in CSF leukocyte count between the patients in doxycycline and ceftriaxone groups
CSF protein concentration
The decline in CSF protein concentration between the patients in doxycycline and ceftriaxone groups.
CSF lactate level
The decline in CSF lactate level between the patients in doxycycline and ceftriaxone groups.
CSF CXCL13 concentration
The decline in CSF CXCL13 concentration wetween the patients in doxycycline and ceftriaxone groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01635530
Brief Title
Study of Lyme Neuroborreliosis
Official Title
Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
4. Oversight
5. Study Description
Brief Summary
The main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in Finland.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Neuroborreliosis
Keywords
doxycycline, ceftriaxone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ceftriaxone
Arm Type
Active Comparator
Arm Description
Treatment of intravenous ceftriaxone (2 g/day), three weeks
Arm Title
Doxycycline
Arm Type
Experimental
Arm Description
Treatment with oral doxycycline (200mg / day), four weeks
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Doxycycline: 100mg tablet two times per day, four weeks
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Description
2 g intravenous once a day, three weeks
Primary Outcome Measure Information:
Title
The improvement of the clinical condition during the study.
Description
The clinical condition of participants will be evaluated with visual analogue scale (from 0 to 10, 0=best) by the participants. The VAS scores are collected before the treatment with antibiotics, and 4 months and 12 months after the treatment.
Time Frame
12 months
Title
The clinical condition evaluated by the participants after 12 months from the treatment
Description
The clinical condition is evaluated with VAS by the participants.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Central spinal fluid (CSF) pleocytosis
Description
The decline in CSF leukocyte count between the patients in doxycycline and ceftriaxone groups
Time Frame
3 weeks
Title
CSF protein concentration
Description
The decline in CSF protein concentration between the patients in doxycycline and ceftriaxone groups.
Time Frame
3 weeks
Title
CSF lactate level
Description
The decline in CSF lactate level between the patients in doxycycline and ceftriaxone groups.
Time Frame
3 weeks
Title
CSF CXCL13 concentration
Description
The decline in CSF CXCL13 concentration wetween the patients in doxycycline and ceftriaxone groups
Time Frame
3 weeks
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 for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled):
Neurological symptoms suggestive of LNB without other obvious reasons
CSF pleocytosis (>4 leukocytes per mikrol)
Intrathecal production of B. burgdorferi specific antibodies
Detection of B. burgdorferi DNA in central spinal fluid
Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled):
Neurological symptoms suggestive of LNB wihtout other obvious reasons
Production of B. burgdorferi spesific antibodies in serum
Erythema migrans during the previous three months
Exclusion Criteria:
pregnancy and breastfeeding
women planning to get pregnant in two months
age under 18
handicapped persons
prisoners
use of any antibiotics two weeks before study treatments begins
allergy for tetracyclines or cephalosporins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jukka Hytönen
Organizational Affiliation
University of Turku
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elisa Kortela
Organizational Affiliation
HYKS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mari Kanerva
Organizational Affiliation
HYKS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Airas
Organizational Affiliation
TYKS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
32133487
Citation
Kortela E, Kanerva MJ, Puustinen J, Hurme S, Airas L, Lauhio A, Hohenthal U, Jalava-Karvinen P, Nieminen T, Finnila T, Haggblom T, Pietikainen A, Koivisto M, Vilhonen J, Marttila-Vaara M, Hytonen J, Oksi J. Oral Doxycycline Compared to Intravenous Ceftriaxone in the Treatment of Lyme Neuroborreliosis: A Multicenter, Equivalence, Randomized, Open-label Trial. Clin Infect Dis. 2021 Apr 26;72(8):1323-1331. doi: 10.1093/cid/ciaa217.
Results Reference
derived
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Study of Lyme Neuroborreliosis
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