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Study of Lyme Neuroborreliosis

Primary Purpose

Lyme Neuroborreliosis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Doxycycline
Ceftriaxone
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lyme Neuroborreliosis focused on measuring doxycycline, ceftriaxone

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled):

  1. Neurological symptoms suggestive of LNB without other obvious reasons
  2. CSF pleocytosis (>4 leukocytes per mikrol)
  3. Intrathecal production of B. burgdorferi specific antibodies
  4. Detection of B. burgdorferi DNA in central spinal fluid

Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled):

  1. Neurological symptoms suggestive of LNB wihtout other obvious reasons
  2. Production of B. burgdorferi spesific antibodies in serum
  3. 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

First Posted
July 3, 2012
Last Updated
May 9, 2019
Sponsor
Turku University Hospital
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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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