Duration of Antibiotic Treatment of Erythema Migrans
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: Erythema Chronicum Migrans
Intervention: doxycycline (Drug); doxycycline (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: University Medical Centre Ljubljana Official(s) and/or principal investigator(s): Franc Strle, MD, Study Chair, Affiliation: UMC Ljubljana
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.
Secondary outcome: Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.
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
UMC Ljubljana, Department of Infectious Diseases, Ljubljana 1525, Slovenia
Additional Information
Starting date: June 2009
Last updated: May 28, 2015
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