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Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

Information source: University Medical Centre Ljubljana
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Additional Information

Starting date: July 2009
Last updated: July 17, 2009

Page last updated: August 23, 2015

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