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| Name | Class |
|---|---|
| University of Ljubljana School of Medicine, Slovenia | OTHER |
| Medical University of Vienna | OTHER |
| Harvard University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| erythema migrans patients treated with antibiotics | Experimental | adult patients with erythema migrans will be treated with oral antibiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antibiotic treatment | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory proteins in erythema migrans patients | 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. | up to 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| gene polymorphisms in erythema migrans patients | The expression of disease-relevant genomic variants will be assessed using ImmunoChip. | at enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| transcriptome profiles in erythema migrans patients | We will use RNA sequencing of individual immune cell subtypes from patients to determine their transcriptome. | at 6 month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dasa Stupica, MD,PhD | Contact | +386 1 5222110 | cerar.dasa@gmail.com | |
| Franc Strle, MD, PhD | Contact | +386 1 5222610 | franc.strle@kclj.si |
| Name | Affiliation | Role |
|---|---|---|
| Franc Strle, MD, PhD | UMC Ljubljana | Study Chair |
| Dasa Stupica, MD, PhD | UMC Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Ljubljana, Department of Infectious Diseases | Recruiting | Ljubljana | 1525 | Slovenia |
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| ID | Term |
|---|---|
| D005929 | Glossitis, Benign Migratory |
| D008193 | Lyme Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D005928 | Glossitis |
| D014060 | Tongue Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| D016905 |
| Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |