Inflammatory Mediators in Erythema Migrans

Erythema Migrans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956212
• Other study ID #: EM Doxy-2017
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2020
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• erythema migrans in patients > 18 years

Exclusion Criteria:

• pregnancy or immunocompromising conditions

• taking antibiotic with antiborrelial activity within 10 days

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans
• Erythema Migrans

Intervention

Drug:
• Doxycycline 7 days
Patient will be treated with doxycycline orally, 100 mg, bid, 7 days
• Doxycycline 14 days
Patient will be treated with doxycycline orally, 100 mg, bid, 14 days

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana School of Medicine, Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	gene polymorphisms in erythema migrans patients	ImmunoChip single-nucleotide polymorphism array for dense genotyping of rheumtic disease-relevant genomic variants will be used.	at enrollment