Duration of Antibiotic Treatment of Erythema Migrans

University Medical Centre Ljubljana306 enrolled

Overview

The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

306

Conditions

Erythema Chronicum Migrans

Interventions

doxycyclineDRUG

doxycycline 100 mg bid, 10 days

doxycyclineDRUG

doxycycline 100 mg bid, 15 days

placeboDRUG

control subjects without a history of Lyme borreliosis

Eligibility

Sex: ALLMin age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, Slovenia

Outcomes

Primary Outcomes

Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.

At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.

Time frame: 1 year follow-up

Secondary Outcomes

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.

6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, concentration difficulties, or irritability) within the preceding week. For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe).

Time frame: 6 months after treatment

Data from ClinicalTrials.gov

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