Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

University Medical Centre Ljubljana

Status: Unknown

Conditions: Suspected Early Lyme Neuroborreliosis

Treatments: Drug: doxycycline; Drug: ceftriaxone

Study type: Interventional

Funder types: Other

Identifiers

NCT00942006

LNB-doxy-ceftriaxone

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

LNB-doxycycline

Active Comparator group

Treatment:

Drug: doxycycline

LNB-ceftriaxone

Active Comparator group

Treatment:

Drug: ceftriaxone