Study of Lyme Neuroborreliosis

Phase 4

Completed

• Conditions: Lyme Neuroborreliosis
• Interventions: Drug: Doxycycline; Drug: Ceftriaxone

• Registration Number: NCT01635530
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-09
• Study Start: 2012-08
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxycycline	Doxycycline	Treatment with oral doxycycline (200mg / day), four weeks
Ceftriaxone	Ceftriaxone	Treatment of intravenous ceftriaxone (2 g/day), three weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 CXCL13 concentration	3 weeks	The decline in CSF CXCL13 concentration wetween 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.

Trial Locations

Locations (2)

Turku University Hospital; 🇫🇮 Turku, Finland

Helsinki University Hospital; 🇫🇮 Helsinki, Finland