Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

NCT ID: NCT00942006

Last Updated: 2009-07-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Suspected Early Lyme Neuroborreliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LNB-doxycycline

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

100 mg bid, 14 days

LNB-ceftriaxone

Group Type ACTIVE_COMPARATOR

ceftriaxone

Intervention Type DRUG

2g x 1 iv, 14 days

Interventions

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doxycycline

100 mg bid, 14 days

Intervention Type DRUG

ceftriaxone

2g x 1 iv, 14 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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UMC Ljubljana

Principal Investigators

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Franc Strle, MD PhD

Role: STUDY_CHAIR

UMC Ljubljana

Locations

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UMC Ljubljana, Department of Infectious Diseases

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Central Contacts

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Katarina Ogrinc, MD PhD

Role: CONTACT

+386 1 522 4217

Franc Strle, PhD MD

Role: CONTACT

+386 1 522 2110

Other Identifiers

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LNB-doxy-ceftriaxone

Identifier Type: -

Identifier Source: org_study_id

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