Duration of Antibiotic Treatment of Erythema Migrans
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: Erythema Chronicum Migrans
Intervention: doxycycline (Drug); doxycycline (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University Medical Centre Ljubljana Official(s) and/or principal investigator(s):
Franc Strle, MD, Study Chair, Affiliation: UMC Ljubljana
Overall contact:
Dasa Cerar, MD, Phone: +386 1 522 2110, Email: cerar.dasa@gmail.com
Summary
The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline
treatment in patients with erythema migrans.
Clinical Details
Official title: Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.
Study design: Other, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Objective sequelae and post-treatment subjective symptoms in patients treated for erythema migrans with doxycycline for 10 or 15 days.
Secondary outcome: Comparison of subjective symptoms between patients treated with doxycycline for 10 or 15 days for erythema migrans and control subjects without a history of Lyme borreliosis.
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- solitary erythema migrans in patients > 15 years
Exclusion Criteria:
- a history of Lyme borreliosis in the past
- pregnancy or lactation
- immunocompromised status
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis
Locations and Contacts
Dasa Cerar, MD, Phone: +386 1 522 2110, Email: cerar.dasa@gmail.com
UMC Ljubljana, Department of Infectious Diseases, Ljubljana 1525, Slovenia; Recruiting
Dasa Cerar, MD, Phone: +386 1 522 2110, Email: cerar.dasa@gmail.com
Franc Strle, MD, Phone: +386 1 5222610, Email: franc.strle@kclj.si
Dasa C, MD, Principal Investigator
Katarina Ogrinc, MD, Sub-Investigator
Petra Bogovic, MD, Sub-Investigator
Eva Ruzic-Sabljic, MD, Sub-Investigator
Tjasa Cerar, MD, Sub-Investigator
Vera Maraspin, MD, Sub-Investigator
Additional Information
Starting date: June 2009
Last updated: September 17, 2009
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