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OpenTrials
Completed

NCT Number: NCT03956212

Inflammatory Mediators in 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.

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Key information

Conditions

Erythema Migrans Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Glossitis Glossitis, Benign Migratory Gram-Negative Bacterial Infections Infections Inflammation Lyme Disease Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spirochaetales Infections Stomatognathic Diseases Tick-Borne Diseases Tongue Diseases Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center 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

Exclusion criteria

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

Treatment and study plan

Doxycycline 7 days

Drug

Patient will be treated with doxycycline orally, 100 mg, bid, 7 days

Doxycycline 14 days

Drug

Patient will be treated with doxycycline orally, 100 mg, bid, 14 days

Primary outcomes

  1. inflammatory proteins in erythema migrans patients

    Time frame: up to 12 months follow-up

    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.

Secondary outcomes

  1. gene polymorphisms in erythema migrans patients

    Time frame: at enrollment

    ImmunoChip single-nucleotide polymorphism array for dense genotyping of rheumtic disease-relevant genomic variants will be used.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University of Ljubljana School of Medicine, Slovenia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 20, 2019
Registry last updated
Nov 3, 2020

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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