Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

Lyme Neuroborreliosis Clinical Trial

Official title:

Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-blind Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138801
• Other study ID #: SSHF813204
• Status: Completed
• Phase: Phase 3
• Start date: March 2004
• Est. completion date: December 2008

Study information

• Verified date: March 2005
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled:

• Intrathecal production of borrelia antibodies;

• White cell count in cerebrospinal fluid (CSF) > 5/mm3;

• Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval;

• Verified acrodermatitis chronica atrophicans.

Exclusion Criteria:

• Allergy to the contents in the medication, or earlier type I reaction to penicillin.

• Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days

• Pregnancy or breastfeeding

• Age < 18 years

Related Conditions & MeSH terms

• Lyme Neuroborreliosis

Intervention

Drug:
• Ceftriaxone

• Doxycycline

Locations

Country	Name	City	State
Norway	Sørlandet Sykehus HF	Kristiansand	Vest-Agder

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway,