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Cytokines and Chemokines in Erythema Migrans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02147249
Recruitment Status : Recruiting
First Posted : May 26, 2014
Last Update Posted : May 4, 2018
University of Ljubljana School of Medicine, Slovenia
Medical University of Vienna
Harvard University
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Erythema Migrans Drug: antibiotic treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
Study Start Date : July 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: erythema migrans patients treated with antibiotics
adult patients with erythema migrans will be treated with oral antibiotics
Drug: antibiotic treatment
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 Measures :
  1. inflammatory proteins in erythema migrans patients [ Time Frame: up to 12 months follow-up ]
    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 :
  1. gene polymorphisms in erythema migrans patients [ Time Frame: at enrollment ]
    The expression of disease-relevant genomic variants will be assessed using ImmunoChip.

Other Outcome Measures:
  1. transcriptome profiles in erythema migrans patients [ Time Frame: at 6 month follow-up ]
    We will use RNA sequencing of individual immune cell subtypes from patients to determine their transcriptome.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • erythema migrans in patients > 18 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02147249

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Contact: Dasa Stupica, MD,PhD +386 1 5222110
Contact: Franc Strle, MD, PhD +386 1 5222610

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UMC Ljubljana, Department of Infectious Diseases Recruiting
Ljubljana, Slovenia, 1525
Contact: Dasa Stupica, MD,PhD    +386 1 5222110   
Contact: Franc Strle, MD,PhD    +386 1 522 2610   
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Medical University of Vienna
Harvard University
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Study Chair: Franc Strle, MD, PhD UMC Ljubljana
Principal Investigator: Dasa Stupica, MD, PhD UMC Ljubljana

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Responsible Party: Franc Strle, MD, PhD, University Medical Centre Ljubljana Identifier: NCT02147249     History of Changes
Other Study ID Numbers: EM-0613
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Keywords provided by Franc Strle, University Medical Centre Ljubljana:
erythema migrans
Lyme borreliosis

Additional relevant MeSH terms:
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Skin Diseases
Lyme Disease
Borrelia Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Skin Manifestations
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents