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Cytokines and Chemokines in Erythema Migrans

Primary Purpose

Erythema Migrans

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
antibiotic treatment
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Erythema Migrans focused on measuring erythema migrans, Lyme borreliosis, inflammation, outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • erythema migrans in patients > 18 years

Exclusion Criteria:

  • pregnancy or lactation
  • taking antibiotic with antiborrelial activity within 10 days

Sites / Locations

  • UMC Ljubljana, Department of Infectious DiseasesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

erythema migrans patients treated with antibiotics

Arm Description

adult patients with erythema migrans will be treated with oral antibiotics

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
The expression of disease-relevant genomic variants will be assessed using ImmunoChip.

Full Information

First Posted
June 24, 2013
Last Updated
April 19, 2019
Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia, Medical University of Vienna, Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT02147249
Brief Title
Cytokines and Chemokines 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
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

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, Medical University of Vienna, Harvard University

4. Oversight

Data Monitoring Committee
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
erythema migrans, 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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
erythema migrans patients treated with antibiotics
Arm Type
Experimental
Arm Description
adult patients with erythema migrans will be treated with oral antibiotics
Intervention Type
Drug
Intervention Name(s)
antibiotic treatment
Intervention Description
Patient will be treated with: doxycycline orally, 100 mg, bid, 14 days or cefuroxime axetil orally, 500 mg, bid, 14 days or amoxicillin orally, 500 mg, tid, 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
The expression of disease-relevant genomic variants will be assessed using ImmunoChip.
Time Frame
at enrollment
Other Pre-specified Outcome Measures:
Title
transcriptome profiles in erythema migrans patients
Description
We will use RNA sequencing of individual immune cell subtypes from patients to determine their transcriptome.
Time Frame
at 6 month follow-up

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 lactation taking antibiotic with antiborrelial activity within 10 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dasa Stupica, MD,PhD
Phone
+386 1 5222110
Email
cerar.dasa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Franc Strle, MD, PhD
Phone
+386 1 5222610
Email
franc.strle@kclj.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD, PhD
Organizational Affiliation
UMC Ljubljana
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dasa Stupica, MD, PhD
Organizational Affiliation
UMC Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Ljubljana, Department of Infectious Diseases
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dasa Stupica, MD,PhD
Phone
+386 1 5222110
Email
cerar.dasa@gmail.com
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD,PhD
Phone
+386 1 522 2610
Email
franc.strle@kclj.si

12. IPD Sharing Statement

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Cytokines and Chemokines in Erythema Migrans

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