Inflammatory Responses in Solitary and Multiple Erythema Migrans

Completed

• Conditions: Erythema Migrans
• Interventions: Other: antibiotic treatment

• Registration Number: NCT03980015
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

The investigators will evaluate differences in host immune responses (levels of cytokines and chemokines, representative of innate, Th1, and Th17 immune responses) in acute sera from adult patients with solitary or multiple erythema migrans.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-01
• Primary Completion: 2016-12-31
• Study Completion: 2019-05-31
• Status Verified: 2019-06
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• erythema migrans in patients > 18 years
• Borrelia afzelii isolated from skin

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
erythema migrans	antibiotic treatment	patients with erythema migrans

Primary Outcome Measures

Name	Time	Method
inflammatory proteins in erythema migrans patients	at enrollment	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 of patients at enrollment (during active infection).

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia