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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03956212
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
Daša Stupica, University Medical Centre Ljubljana

Study Description
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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

Study Design
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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


Arms and Interventions
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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


Outcome Measures
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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.


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

Inclusion Criteria:

  • erythema migrans in patients > 18 years

Exclusion Criteria:

  • pregnancy or immunocompromising conditions
  • taking antibiotic with antiborrelial activity within 10 days
Contacts and Locations
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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


Locations
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Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Investigators
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Principal Investigator: Daša Stupica, MD PhD University Medical Centre Ljubljana
More Information
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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
Inflammation
Outcome
Additional relevant MeSH terms:
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Erythema Chronicum Migrans
Glossitis, Benign Migratory
Erythema
Skin Diseases
Skin Manifestations
Lyme Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Borrelia Infections
Spirochaetales Infections
Skin Diseases, Bacterial
 Skin Diseases, Infectious
Tick-Borne Diseases
Vector Borne Diseases
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents