Study of Lyme Neuroborreliosis

Lyme Neuroborreliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635530
• Other study ID #: T1/2012
• Status: Completed
• Phase: Phase 4
• Start date: August 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2019
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lyme Neuroborreliosis

Intervention

Drug:
• Doxycycline
Doxycycline: 100mg tablet two times per day, four weeks
• Ceftriaxone
2 g intravenous once a day, three weeks

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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