Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by University Medical Centre Ljubljana. Recruitment status was Not yet recruiting

First Received on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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
Active Comparator: LNB-doxycycline	Drug: doxycycline 100 mg bid, 14 days
Active Comparator: LNB-ceftriaxone	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

Sponsors and Collaborators

University Medical Centre Ljubljana

Investigators

Study Chair:

Franc Strle, MD PhD

UMC Ljubljana

More Information

No publications provided

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

Lyme Neuroborreliosis
Central Nervous System Bacterial Infections
Bacterial Infections
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

Ceftriaxone
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012