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
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
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
NCT ID
NCT00910715
First Posted
May 28, 2009
Last Updated
May 4, 2017
Sponsor
University Medical Centre Ljubljana
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
Learn more about this trial
Duration of Antibiotic Treatment of Erythema Migrans
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