Study of Lyme Neuroborreliosis

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 4

Conditions: Lyme Neuroborreliosis

Treatments: Drug: Doxycycline; Drug: Ceftriaxone

Study type: Interventional

Funder types: Other

Identifiers

NCT01635530

T1/2012

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Ceftriaxone

Active Comparator group

Description:

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

Treatment:

Drug: Ceftriaxone

Doxycycline

Experimental group

Description:

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

Treatment:

Drug: Doxycycline