Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

Phase 3

Completed

• Conditions: Lyme Neuroborreliosis
• Interventions: Drug: Doxycycline; Drug: Ceftriaxone

• Registration Number: NCT00138801
• Lead Sponsor: Sorlandet Hospital HF

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Status Verified: 2005-03
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Primary Completion: 2008-03
• Study Completion: 2008-12
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Doxycycline	Doxycycline
2	Ceftriaxone	cephtriaxone

Trial Locations

Locations (1)

Sørlandet Sykehus HF; 🇳🇴 Kristiansand, Vest-Agder, Norway