Skip to content

Inflammatory Mediators in Erythema Migrans

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03956212
Enrollment
150
Registered
2019-05-20
Start date
2017-06-01
Completion date
2020-10-31
Last updated
2020-11-03

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

Conditions

Erythema Migrans

Keywords

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

Patient will be treated with doxycycline orally, 100 mg, bid, 7 days

DRUGDoxycycline 14 days

Patient will be treated with doxycycline orally, 100 mg, bid, 14 days

Sponsors

University of Ljubljana School of Medicine, Slovenia
CollaboratorOTHER
University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* erythema migrans in patients \> 18 years

Exclusion criteria

* pregnancy or immunocompromising conditions * taking antibiotic with antiborrelial activity within 10 days

Design outcomes

Primary

MeasureTime frameDescription
inflammatory proteins in erythema migrans patientsup to 12 months follow-upThe 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

MeasureTime frameDescription
gene polymorphisms in erythema migrans patientsat enrollmentImmunoChip single-nucleotide polymorphism array for dense genotyping of rheumtic disease-relevant genomic variants will be used.

Countries

Slovenia

Outcome results

None listed

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