Inflammatory Mediators in Erythema Migrans

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

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.

Study Overview

• Status: Completed
• Conditions: Erythema Migrans
• Intervention / Treatment: Drug: Doxycycline 7 days; Drug: Doxycycline 14 days

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia
    • University Medical Center Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• erythema migrans in patients > 18 years

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: erythema migrans patients treated with doxycycline; adult patients with erythema migrans will be treated with oral doxycycline	Drug: Doxycycline 7 days; Patient will be treated with doxycycline orally, 100 mg, bid, 7 days; Drug: Doxycycline 14 days; Patient will be treated with doxycycline orally, 100 mg, bid, 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: University of Ljubljana School of Medicine, Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Inflammation; Outcome; Lyme Borreliosis
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Skin Manifestations; Skin Diseases, Bacterial; Tick-Borne Diseases; Borrelia Infections; Spirochaetales Infections; Tongue Diseases; Glossitis; Lyme Disease; Erythema; Erythema Chronicum Migrans; Glossitis, Benign Migratory; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: EM Doxy-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No