Inflammatory Responses in Solitary and Multiple Erythema Migrans

NCT ID: NCT03980015

Last Updated: 2019-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-01

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Erythema Migrans

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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erythema migrans

patients with erythema migrans

antibiotic treatment

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana School of Medicine, Slovenia

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Daša Stupica

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daša Stupica, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

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University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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MEM vs EM cyto

Identifier Type: -

Identifier Source: org_study_id

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