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Clinical Trials/NCT02147249
NCT02147249
Unknown
Not Applicable

Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans

University Medical Centre Ljubljana1 site in 1 country150 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
antibiotic treatment
Conditions
Erythema Migrans
Sponsor
University Medical Centre Ljubljana
Enrollment
150
Locations
1
Primary Endpoint
inflammatory proteins in erythema migrans patients
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
December 31, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Franc Strle

MD, PhD

University Medical Centre Ljubljana

Eligibility Criteria

Inclusion Criteria

  • erythema migrans in patients \> 18 years

Exclusion Criteria

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

Arms & Interventions

erythema migrans patients treated with antibiotics

adult patients with erythema migrans will be treated with oral antibiotics

Intervention: antibiotic treatment

Outcomes

Primary Outcomes

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 Outcomes

  • gene polymorphisms in erythema migrans patients(at enrollment)

Study Sites (1)

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