Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

This study is not yet open for participant recruitment.

Verified by University Medical Centre Ljubljana, July 2009

First Received: July 17, 2009 No Changes Posted

Sponsor:	University Medical Centre Ljubljana
Information provided by:	University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:	NCT00942006

Purpose

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.

Condition	Intervention
Suspected Early Lyme Neuroborreliosis	Drug: doxycycline Drug: ceftriaxone

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.

Resource links provided by NLM:

Drug Information available for: Doxycycline Doxycycline hyclate Ceftriaxone Ceftriaxone Sodium Doxycycline calcium

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

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. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	July 2009
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
LNB-doxycycline: Active Comparator	Drug: doxycycline 100 mg bid, 14 days
LNB-ceftriaxone: Active Comparator	Drug: ceftriaxone 2g x 1 iv, 14 days

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942006

Contacts

Contact: Katarina Ogrinc, MD PhD	+386 1 522 4217	katarina.ogrinc1@guest.arnes.si
Contact: Franc Strle, PhD MD	+386 1 522 2110	franc.strle@kclj.si

Locations

Slovenia
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia, 1525
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia, 1525

Sponsors and Collaborators

University Medical Centre Ljubljana

Investigators

Study Chair:

Franc Strle, MD PhD

UMC Ljubljana

More Information

No publications provided

Responsible Party:	UMC Ljubljana ( Katarina Ogrinc MD PhD )
Study ID Numbers:	LNB-doxy-ceftriaxone
Study First Received:	July 17, 2009
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00942006 History of Changes
Health Authority:	Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:

Lyme neuroborreliosis
Lyme borreliosis
erythema migrans
doxycycline treatment

ceftriaxone treatment
outcome
subjective symptoms

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Antiprotozoal Agents
Borrelia Infections
Lyme Disease
Nervous System Diseases
Central Nervous System Diseases
Ceftriaxone
Pharmacologic Actions
Tick-Borne Diseases

Gram-Negative Bacterial Infections
Antimalarials
Anti-Bacterial Agents
Antiparasitic Agents
Central Nervous System Infections
Spirochaetales Infections
Therapeutic Uses
Central Nervous System Bacterial Infections
Lyme Neuroborreliosis
Doxycycline

ClinicalTrials.gov processed this record on February 08, 2010