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Duration of Antibiotic Treatment of Erythema Migrans

Primary Purpose

Erythema Chronicum Migrans

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
doxycycline
doxycycline
placebo
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Erythema Chronicum Migrans focused on measuring erythema migrans, Lyme borreliosis, doxycycline treatment, outcome, subjective symptoms

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UMC Ljubljana, Department of Infectious Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

EM-10 days doxycycline

EM-doxycycline 15 days

controls

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
May 28, 2009
Last Updated
May 4, 2017
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT00910715
Brief Title
Duration of Antibiotic Treatment of Erythema Migrans
Official Title
Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema Chronicum Migrans
Keywords
erythema migrans, Lyme borreliosis, doxycycline treatment, outcome, subjective symptoms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EM-10 days doxycycline
Arm Type
Active Comparator
Arm Title
EM-doxycycline 15 days
Arm Type
Active Comparator
Arm Title
controls
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
doxycycline
Intervention Description
doxycycline 100 mg bid, 10 days
Intervention Type
Drug
Intervention Name(s)
doxycycline
Intervention Description
doxycycline 100 mg bid, 15 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
control subjects without a history of Lyme borreliosis
Primary Outcome Measure Information:
Title
Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.
Description
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 Outcome Measure Information:
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD
Organizational Affiliation
UMC Ljubljana
Official's Role
Study Chair
Facility Information:
Facility Name
UMC Ljubljana, Department of Infectious Diseases
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30075748
Citation
Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.
Results Reference
derived
PubMed Identifier
22523260
Citation
Stupica D, Lusa L, Ruzic-Sabljic E, Cerar T, Strle F. Treatment of erythema migrans with doxycycline for 10 days versus 15 days. Clin Infect Dis. 2012 Aug;55(3):343-50. doi: 10.1093/cid/cis402. Epub 2012 Apr 20.
Results Reference
derived

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Duration of Antibiotic Treatment of Erythema Migrans

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