Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis
Information source: University Medical Centre Ljubljana
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Suspected Early Lyme Neuroborreliosis
Intervention: doxycycline (Drug); ceftriaxone (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University Medical Centre Ljubljana Official(s) and/or principal investigator(s):
Franc Strle, MD PhD, Study Chair, Affiliation: UMC Ljubljana
Overall contact:
Katarina Ogrinc, MD PhD, Phone: +386 1 522 4217, Email: katarina.ogrinc1@guest.arnes.si
Summary
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.
Clinical Details
Official title: Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Katarina Ogrinc, MD PhD, Phone: +386 1 522 4217, Email: katarina.ogrinc1@guest.arnes.si
UMC Ljubljana, Department of Infectious Diseases, Ljubljana 1525, Slovenia
UMC Ljubljana, Department of Infectious Diseases, Ljubljana 1525, Slovenia
Additional Information
Starting date: July 2009
Ending date: November 2011
Last updated: July 17, 2009
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