Study of Lyme Neuroborreliosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

NCT00138801

Lyme Neuroborreliosis

COMPLETED PHASE3

Study on Early Lyme Neuroborreliosis

NCT00910533

Nervous System Lyme Borreliosis

UNKNOWN NA

Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

NCT00942006

Suspected Early Lyme Neuroborreliosis

UNKNOWN NA

Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis

NCT02553473

Neuroborreliosis, Borrelia Burgdorferi

COMPLETED PHASE3

A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

NCT00001539

Lyme Disease

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lyme Neuroborreliosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ceftriaxone

Treatment of intravenous ceftriaxone (2 g/day), three weeks

Group Type ACTIVE_COMPARATOR

Ceftriaxone

Intervention Type DRUG

2 g intravenous once a day, three weeks

Doxycycline

Treatment with oral doxycycline (200mg / day), four weeks

Group Type EXPERIMENTAL

Doxycycline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxycycline

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

Intervention Type DRUG

Ceftriaxone

2 g intravenous once a day, three weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No