Study of Lyme Neuroborreliosis

Study Overview
=================
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.

Official Title
-----------------
Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment

Conditions
-----------------
Lyme Neuroborreliosis

Intervention / Treatment
-----------------
* Drug: Doxycycline
* Drug: Ceftriaxone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ceftriaxone<br>Treatment of intravenous ceftriaxone (2 g/day), three weeks | Drug: Ceftriaxone<br>* 2 g intravenous once a day, three weeks<br>|
| Experimental: Doxycycline<br>Treatment with oral doxycycline (200mg / day), four weeks | Drug: Doxycycline<br>* Doxycycline: 100mg tablet two times per day, four weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| The clinical condition evaluated by the participants after 12 months from the treatment | The clinical condition is evaluated with VAS by the participants. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central spinal fluid (CSF) pleocytosis | The decline in CSF leukocyte count between the patients in doxycycline and ceftriaxone groups | 3 weeks | 
| CSF protein concentration | The decline in CSF protein concentration between the patients in doxycycline and ceftriaxone groups. | 3 weeks | 
| CSF lactate level | The decline in CSF lactate level between the patients in doxycycline and ceftriaxone groups. | 3 weeks | 
| CSF CXCL13 concentration | The decline in CSF CXCL13 concentration wetween the patients in doxycycline and ceftriaxone groups | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
doxycycline, ceftriaxone