Cytokines and Chemokines in Erythema Migrans

Overview

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.

Full Title of Study: “Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: erythema migrans patients treated with antibiotics
    • adult patients with erythema migrans will be treated with oral antibiotics

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • gene polymorphisms in erythema migrans patients
    • Time Frame: at enrollment
    • The expression of disease-relevant genomic variants will be assessed using ImmunoChip.

Participating in This Clinical Trial

Inclusion Criteria

  • erythema migrans in patients > 18 years

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Centre Ljubljana
  • Collaborator
    • University of Ljubljana School of Medicine, Slovenia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Franc Strle, MD, PhD – University Medical Centre Ljubljana
  • Overall Official(s)
    • Franc Strle, MD, PhD, Study Chair, UMC Ljubljana
    • Dasa Stupica, MD, PhD, Principal Investigator, UMC Ljubljana
  • Overall Contact(s)
    • Dasa Stupica, MD,PhD, +386 1 5222110, cerar.dasa@gmail.com

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