Cytokines and Chemokines 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: Recruiting

Administrative data

• NCT number: NCT02147249
• Other study ID #: EM-0613
• Status: Recruiting
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2019
• Source: University Medical Centre Ljubljana
• Contact: Dasa Stupica, MD,PhD
• Phone: +386 1 5222110
• Email: cerar.dasa[@]gmail.com
• 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: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• 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 lactation

• taking antibiotic with antiborrelial activity within 10 days

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans
• Erythema Migrans

Intervention

Drug:
• antibiotic 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

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana, Department of Infectious Diseases	Ljubljana

Sponsors (4)

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

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
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	The expression of disease-relevant genomic variants will be assessed using ImmunoChip.	at enrollment