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OpenTrials
Completed

NCT Number: NCT03980015

Inflammatory Responses in Solitary and Multiple Erythema Migrans

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antibiotic treatment

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

Primary outcomes

  1. inflammatory proteins in erythema migrans patients

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University of Ljubljana School of Medicine, Slovenia

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2016
Study completion
2019
First posted
Jun 10, 2019
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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