Inflammatory Responses in Solitary and Multiple Erythema Migrans

Erythema Migrans Clinical Trial

Official title:

Inflammatory Responses in Borrelia Afzelii Culture Positive Patients With Early Disseminated or Early Localized Lyme Borreliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980015
• Other study ID #: MEM vs EM cyto
• Status: Completed
• Start date: June 1, 2006
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: May 31, 2019
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans
• Erythema Migrans

Intervention

Other:
• antibiotic treatment
Patients were treated with: ceftriaxone intravenously 2 g OD for 14 days or doxycycline orally 100 mg bid for 10 to 14 days or cefuroxime axetil orally 500 mg bid for 14 days or amoxicillin orally 500 mg tid for 14 days

Locations

Country	Name	City	State
Slovenia	University Medical Centre 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 of patients at enrollment (during active infection).	at enrollment