Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
Overview
- Phase
- Not Applicable
- Intervention
- Doxycycline 7 days
- Conditions
- Erythema Migrans
- Sponsor
- University Medical Centre Ljubljana
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- inflammatory proteins in erythema migrans patients
- Status
- Completed
- Last Updated
- 5 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.
Investigators
Daša Stupica
Principal Investigator
University Medical Centre Ljubljana
Eligibility Criteria
Inclusion Criteria
- •erythema migrans in patients \> 18 years
Exclusion Criteria
- •pregnancy or immunocompromising conditions
- •taking antibiotic with antiborrelial activity within 10 days
Arms & Interventions
erythema migrans patients treated with doxycycline
adult patients with erythema migrans will be treated with oral doxycycline
Intervention: Doxycycline 7 days
erythema migrans patients treated with doxycycline
adult patients with erythema migrans will be treated with oral doxycycline
Intervention: Doxycycline 14 days
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)