Back to resultsDuration of Doxycycline Treatment in EM Patients
Primary Purpose
Erythema Chronicum Migrans
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Doxycycline 100 MG Oral Tablet bid, 7 days
Doxycycline 100 MG Oral Tablet bid, 14 days
Controls without a history of lyme disease.
Sponsored by
About this trial
This is an interventional treatment trial for Erythema Chronicum Migrans
Eligibility Criteria
Inclusion Criteria:
- solitary erythema migrans
Exclusion Criteria:
- pregnancy or lactation
- immunocompromised
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- multiple erythema migrans or extracutaneous manifestations of lyme borreliosis
Sites / Locations
- University Medical centzer Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
EM-7 days doxycycline
EM-14 days doxycycline
Controls
Arm Description
Outcomes
Primary Outcome Measures
Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days
Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.
Secondary Outcome Measures
Comparison of nonspecific symptoms in patients with erythema migrans and control subjects
Number of patients after treatment with doxycycline for 7 or 14 days for erythema migrans and number of control subjects (without a history o Lyme borreliosis) with nonspecific symptoms.
Full Information
NCT ID
NCT03153267
First Posted
March 16, 2017
Last Updated
March 24, 2020
Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia
1. Study Identification
Unique Protocol Identification Number
NCT03153267
Brief Title
Duration of Doxycycline Treatment in EM Patients
Official Title
Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy of 7-day versus 14-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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EM-7 days doxycycline
Arm Type
Active Comparator
Arm Title
EM-14 days doxycycline
Arm Type
Active Comparator
Arm Title
Controls
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Doxycycline 100 MG Oral Tablet bid, 7 days
Intervention Description
Patients will receive doxycycline for 7 days.
Intervention Type
Drug
Intervention Name(s)
Doxycycline 100 MG Oral Tablet bid, 14 days
Intervention Description
Patients will receive doxycycline for 14 days.
Intervention Type
Drug
Intervention Name(s)
Controls without a history of lyme disease.
Intervention Description
No intervention.
Primary Outcome Measure Information:
Title
Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days
Description
Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.
Time Frame
At 12 months after enrollment.
Secondary Outcome Measure Information:
Title
Comparison of nonspecific symptoms in patients with erythema migrans and control subjects
Description
Number of patients after treatment with doxycycline for 7 or 14 days for erythema migrans and number of control subjects (without a history o Lyme borreliosis) with nonspecific symptoms.
Time Frame
At 12 months after enrollment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
solitary erythema migrans
Exclusion Criteria:
pregnancy or lactation
immunocompromised
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
Daša Stupica, MD PhD
Organizational Affiliation
University Mecical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical centzer Ljubljana
City
Ljubljana
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36209759
Citation
Stupica D, Collinet-Adler S, Blagus R, Gomiscek A, Cerar Kisek T, Ruzic-Sabljic E, Veluscek M. Treatment of erythema migrans with doxycycline for 7 days versus 14 days in Slovenia: a randomised open-label non-inferiority trial. Lancet Infect Dis. 2023 Mar;23(3):371-379. doi: 10.1016/S1473-3099(22)00528-X. Epub 2022 Oct 6.
Results Reference
derived
Learn more about this trial
Duration of Doxycycline Treatment in EM Patients
We'll reach out to this number within 24 hrs