Suspected Early Lyme Neuroborreliosis Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 200 |
| Est. completion date | November 2011 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Slovenia | UMC Ljubljana, Department of Infectious Diseases | Ljubljana |
| Lead Sponsor | Collaborator |
|---|---|
| University Medical Centre Ljubljana |
Slovenia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |