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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 chronic atrophic dermatitis to gain better insight into pathogenesis of chronic infection with Borrelia burgdorferi sensu lato.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACA-doxy 14 days | Active Comparator | patients with chronic atrophic acrodermatitis treated with doxycycline for 14 days |
|
| ACA-doxy 28 days | Active Comparator | patients with chronic atrophic acrodermatitis treated with doxycycline for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxycycline orally, 100 mg, bid, 14 days | Drug |
| ||
| doxycycline orally, 100 mg, bid, 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory proteins in patients with chronic atrophic dermatitis | 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. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical characteristics of patients with chronic atrophic dermatitis treated with doxycycline for 14 or 28 days | at enrollment, at 2, 6 12 and 24 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| gene polymorphisms in patients with chronic atrophic dermatitis | The expression of disease-relevant genomic variants will be assessed using ImmunoChip. | at enrollment, at 6 months follow-up |
| transcriptome profiles in patients with chronic atrophic dermatitis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dasa Stupica, MD, PhD | Contact | +386 1 522 2110 | cerar.dasa@gmail.com | |
| Franc Strle, MD, PhD | Contact | +386 1 522 2610 | 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 |
|---|---|
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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| Drug |
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We will use RNA sequencing of individual immune cell subtypes from patients to determine their transcriptome.
| at enrollment |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |