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Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

Primary Purpose

Suspected Early Lyme Neuroborreliosis

Status

Unknown status

Phase

Not Applicable

Locations

Slovenia

Study Type

Interventional

Intervention

doxycycline

ceftriaxone

About this trial

This is an interventional treatment trial for Suspected Early Lyme Neuroborreliosis focused on measuring Lyme neuroborreliosis, Lyme borreliosis, erythema migrans, doxycycline treatment, ceftriaxone treatment, outcome, subjective symptoms

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UMC Ljubljana, Department of Infectious Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

LNB-doxycycline

LNB-ceftriaxone

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00942006

First Posted

July 17, 2009

Last Updated

July 17, 2009

Sponsor

University Medical Centre Ljubljana

1. Study Identification

Unique Protocol Identification Number

NCT00942006

Brief Title

Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

Official Title

Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

November 2010 (Anticipated)

Study Completion Date

November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suspected Early Lyme Neuroborreliosis

Keywords

Lyme neuroborreliosis, Lyme borreliosis, erythema migrans, doxycycline treatment, ceftriaxone treatment, outcome, subjective symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LNB-doxycycline

Arm Type

Active Comparator

Arm Title

LNB-ceftriaxone

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

doxycycline

Intervention Description

100 mg bid, 14 days

Intervention Type

Drug

Intervention Name(s)

ceftriaxone

Intervention Description

2g x 1 iv, 14 days

Primary Outcome Measure Information:

Title

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.

Time Frame

1 year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katarina Ogrinc, MD PhD

Phone

+386 1 522 4217

katarina.ogrinc1@guest.arnes.si

First Name & Middle Initial & Last Name or Official Title & Degree

Franc Strle, PhD MD

Phone

+386 1 522 2110

franc.strle@kclj.si

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franc Strle, MD PhD

Organizational Affiliation

UMC Ljubljana

Official's Role

Study Chair

Facility Information:

Facility Name

UMC Ljubljana, Department of Infectious Diseases

City

Ljubljana

ZIP/Postal Code

1525

Country

Slovenia

12. IPD Sharing Statement

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Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

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