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Inflammatory Mediators 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: NCT03956212
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
Daša Stupica, 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: Doxycycline 7 days Drug: Doxycycline 14 days 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
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: erythema migrans patients treated with doxycycline
adult patients with erythema migrans will be treated with oral doxycycline
Drug: Doxycycline 7 days
Patient will be treated with doxycycline orally, 100 mg, bid, 7 days

Drug: Doxycycline 14 days
Patient will be treated with doxycycline orally, 100 mg, bid, 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 ]
    ImmunoChip single-nucleotide polymorphism array for dense genotyping of rheumtic disease-relevant genomic variants will be used.

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 immunocompromising conditions
  • 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): NCT03956212

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Contact: Daša Stupica, MD PhD +386 31 689324
Contact: Maša Velušček, MD PhD +38631332904

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University Medical Center Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Daša Stupica, MD, PhD    +386 31 689 324   
Contact: Maša Velušček, MD    +386 1 522 21 10   
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
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Principal Investigator: Daša Stupica, MD PhD University Medical Centre Ljubljana

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Responsible Party: Daša Stupica, Principal Investigator, University Medical Centre Ljubljana Identifier: NCT03956212     History of Changes
Other Study ID Numbers: EM Doxy-2017
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daša Stupica, University Medical Centre Ljubljana:
Lyme Borreliosis

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