Effect of Intravenous Ceftriaxone and Oral Doxycycline for 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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-12-31

Brief Summary

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The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.

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Detailed Description

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Conditions

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Lyme Neuroborreliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Doxycycline

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

2

cephtriaxone

Group Type ACTIVE_COMPARATOR

Ceftriaxone

Intervention Type DRUG

Interventions

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Ceftriaxone

Intervention Type DRUG

Doxycycline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled:

* Intrathecal production of borrelia antibodies;
* White cell count in cerebrospinal fluid (CSF) \> 5/mm3;
* Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval;
* Verified acrodermatitis chronica atrophicans.

Exclusion Criteria

* Allergy to the contents in the medication, or earlier type I reaction to penicillin.
* Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days
* Pregnancy or breastfeeding
* Age \< 18 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No