Cytokines and Chemokines in Erythema Migrans

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02147249

Enrollment

150

Registered

2014-05-26

Start date

2013-07-31

Completion date

2020-12-31

Last updated

2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erythema Migrans

Keywords

erythema migrans, Lyme borreliosis, inflammation, outcome

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.

Interventions

DRUGantibiotic treatment

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* erythema migrans in patients \> 18 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
gene polymorphisms in erythema migrans patients	at enrollment	The expression of disease-relevant genomic variants will be assessed using ImmunoChip.

Other

Measure	Time frame	Description
transcriptome profiles in erythema migrans patients	at 6 month follow-up	We will use RNA sequencing of individual immune cell subtypes from patients to determine their transcriptome.

Countries

Slovenia

Contacts

Primary ContactDasa Stupica, MD,PhD

cerar.dasa@gmail.com+386 1 5222110

Backup ContactFranc Strle, MD, PhD

franc.strle@kclj.si+386 1 5222610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026