Inflammatory Mediators in Erythema Migrans
- Conditions
- Erythema Migrans
- Interventions
- Registration Number
- NCT03956212
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- erythema migrans in patients > 18 years
- pregnancy or immunocompromising conditions
- taking antibiotic with antiborrelial activity within 10 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description erythema migrans patients treated with doxycycline Doxycycline 14 days adult patients with erythema migrans will be treated with oral doxycycline erythema migrans patients treated with doxycycline Doxycycline 7 days adult patients with erythema migrans will be treated with oral doxycycline
- Primary Outcome Measures
Name Time Method inflammatory proteins in erythema migrans patients 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
Name Time Method gene polymorphisms in erythema migrans patients at enrollment ImmunoChip single-nucleotide polymorphism array for dense genotyping of rheumtic disease-relevant genomic variants will be used.
Trial Locations
- Locations (1)
University Medical Center Ljubljana
🇸🇮Ljubljana, Slovenia