Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

Sorlandet Hospital HF

Status and phase: Completed; Phase 3

Conditions: Lyme Neuroborreliosis

Treatments: Drug: Doxycycline; Drug: Ceftriaxone

Study type: Interventional

Funder types: Other

Identifiers

NCT00138801

SSHF813204

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

1

Active Comparator group

Description:

Doxycycline

Treatment:

Drug: Doxycycline

2

Active Comparator group

Description:

cephtriaxone

Treatment:

Drug: Ceftriaxone