Study of Lyme Neuroborreliosis

Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01635530

Enrollment

210

Registered

2012-07-09

Start date

2012-08-31

Completion date

2018-12-31

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme Neuroborreliosis

Keywords

doxycycline, ceftriaxone

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.

Interventions

DRUGDoxycycline

Doxycycline: 100mg tablet two times per day, four weeks

DRUGCeftriaxone

2 g intravenous once a day, three weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The improvement of the clinical condition during the study.	12 months	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	12 months	The clinical condition is evaluated with VAS by the participants.

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026