Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

Not Applicable

• Conditions: Suspected Early Lyme Neuroborreliosis
• Interventions: Drug: ceftriaxone; Drug: doxycycline

• Registration Number: NCT00942006
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study Start: 2009-07
• Study First Submitted: 2009-07-17
• Study First Submitted QC: 2009-07-17
• Last Update Submitted: 2009-07-17
• Study First Posted: 2009-07-20
• Last Update Posted: 2009-07-20
• Primary Completion: 2010-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age >15 years
• erythema migrans in 4 months period before neurologic symptoms
• normal CSF cell count
• absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).

Exclusion Criteria

• pregnancy
• lactation
• allergy on doxycycline and ceftriaxone
• immune deficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNB-ceftriaxone	ceftriaxone	-
LNB-doxycycline	doxycycline	-

Primary Outcome Measures

Name	Time	Method
Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.	1 year follow-up

Trial Locations

Locations (1)

UMC Ljubljana, Department of Infectious Diseases; 🇸🇮 Ljubljana, Slovenia