Duration of Antibiotic Treatment of Erythema Migrans

Not Applicable

Completed

• Conditions: Erythema Chronicum Migrans
• Interventions: Drug: placebo; Drug: doxycycline

• Registration Number: NCT00910715
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-29
• Study Start: 2009-06
• Study First Posted: 2009-06-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2011-10-05
• Results First Submitted QC: 2012-06-13
• Results First Posted: 2012-07-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls	placebo	-
EM-10 days doxycycline	doxycycline	-
EM-doxycycline 15 days	doxycycline	-

Primary Outcome Measures

Name	Time	Method
Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.	1 year follow-up	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.

Secondary Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

UMC Ljubljana, Department of Infectious Diseases; 🇸🇮 Ljubljana, Slovenia