Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

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

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.

Study Overview

• Status: Unknown
• Conditions: Suspected Early Lyme Neuroborreliosis
• Intervention / Treatment: Drug: doxycycline; Drug: ceftriaxone

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katarina Ogrinc, MD PhD; Phone Number: +386 1 522 4217; Email: katarina.ogrinc1@guest.arnes.si
• Study Contact Backup: Name: Franc Strle, PhD MD; Phone Number: +386 1 522 2110; Email: franc.strle@kclj.si

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LNB-doxycycline	Drug: doxycycline; 100 mg bid, 14 days
Active Comparator: LNB-ceftriaxone	Drug: ceftriaxone; 2g x 1 iv, 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 year follow-up

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Study Chair: Franc Strle, MD PhD, UMC Ljubljana

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): November 1, 2010
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: July 17, 2009
• First Submitted That Met QC Criteria: July 17, 2009
• First Posted (Estimate): July 20, 2009

Study Record Updates

• Last Update Posted (Estimate): July 20, 2009
• Last Update Submitted That Met QC Criteria: July 17, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: outcome; Lyme borreliosis; Lyme neuroborreliosis; erythema migrans; doxycycline treatment; ceftriaxone treatment; subjective symptoms
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Tick-Borne Diseases; Borrelia Infections; Spirochaetales Infections; Lyme Disease; Lyme Neuroborreliosis; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Ceftriaxone; Doxycycline
• Other Study ID Numbers: LNB-doxy-ceftriaxone