Back to resultsInflammatory Mediators in Erythema Migrans
Primary Purpose
Erythema Migrans
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Doxycycline 7 days
Doxycycline 14 days
Sponsored by
About this trial
This is an interventional basic science trial for Erythema Migrans focused on measuring Lyme Borreliosis, Inflammation, Outcome
Eligibility Criteria
Inclusion Criteria:
- erythema migrans in patients > 18 years
Exclusion Criteria:
- pregnancy or immunocompromising conditions
- taking antibiotic with antiborrelial activity within 10 days
Sites / Locations
- University Medical Center Ljubljana
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
erythema migrans patients treated with doxycycline
Arm Description
adult patients with erythema migrans will be treated with oral doxycycline
Outcomes
Primary Outcome Measures
inflammatory proteins in erythema migrans patients
The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum and if available, skin, of patients during active infection and after treatment.
Secondary Outcome Measures
gene polymorphisms in erythema migrans patients
ImmunoChip single-nucleotide polymorphism array for dense genotyping of rheumtic disease-relevant genomic variants will be used.
Full Information
NCT ID
NCT03956212
First Posted
May 15, 2019
Last Updated
November 2, 2020
Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia
1. Study Identification
Unique Protocol Identification Number
NCT03956212
Brief Title
Inflammatory Mediators in Erythema Migrans
Official Title
Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
October 31, 2020 (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
5. Study Description
Brief Summary
The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema Migrans
Keywords
Lyme Borreliosis, Inflammation, Outcome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
erythema migrans patients treated with doxycycline
Arm Type
Experimental
Arm Description
adult patients with erythema migrans will be treated with oral doxycycline
Intervention Type
Drug
Intervention Name(s)
Doxycycline 7 days
Intervention Description
Patient will be treated with doxycycline orally, 100 mg, bid, 7 days
Intervention Type
Drug
Intervention Name(s)
Doxycycline 14 days
Intervention Description
Patient will be treated with doxycycline orally, 100 mg, bid, 14 days
Primary Outcome Measure Information:
Title
inflammatory proteins in erythema migrans patients
Description
The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum and if available, skin, of patients during active infection and after treatment.
Time Frame
up to 12 months follow-up
Secondary Outcome Measure Information:
Title
gene polymorphisms in erythema migrans patients
Description
ImmunoChip single-nucleotide polymorphism array for dense genotyping of rheumtic disease-relevant genomic variants will be used.
Time Frame
at enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
erythema migrans in patients > 18 years
Exclusion Criteria:
pregnancy or immunocompromising conditions
taking antibiotic with antiborrelial activity within 10 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daša Stupica, MD PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Ljubljana
City
Ljubljana
Country
Slovenia
12. IPD Sharing Statement
Learn more about this trial
Inflammatory Mediators in Erythema Migrans
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