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Inflammatory Mediators in Erythema Migrans

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ClinicalTrials.gov Identifier: NCT03956212
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : November 3, 2020
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)
Actual Enrollment : 150 participants
Allocation: N/A
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
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : October 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 ClinicalTrials.gov identifier (NCT number): NCT03956212

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University Medical Center Ljubljana
Ljubljana, Slovenia
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
ClinicalTrials.gov Identifier: NCT03956212    
Other Study ID Numbers: EM Doxy-2017
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020

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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
Lyme Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Borrelia Infections
Spirochaetales Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Tick-Borne Diseases
Vector Borne Diseases
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents