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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00910533
Other study ID # LNB-0509
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2009
Est. completion date December 2020

Study information

Verified date May 2017
Source University Medical Centre Ljubljana
Contact Dasa Stupica, MD
Phone +38615222110
Email cerar.dasa@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2020
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria:

- erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old

Exclusion Criteria:

- pregnancy

- lactation

- history of adverse reaction to a beta-lactam antibiotic

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ceftriaxone
ceftriaxone 2 g od i.v. for 14 days

Locations

Country Name City State
Slovenia UMC Ljubljana, Department of Infectious Diseases Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis 1 year follow-up
Secondary Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis 1 year follow-up