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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

Page last updated: August 23, 2015

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