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出境医 / 临床实验 / Inflammatory Mediators in Erythema Migrans

Inflammatory Mediators in Erythema Migrans

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Erythema Migrans Drug: Doxycycline 7 days Drug: Doxycycline 14 days Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : October 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: erythema migrans patients treated with doxycycline
adult patients with erythema migrans will be treated with oral doxycycline
 Drug: Doxycycline 7 days
Patient will be treated with doxycycline orally, 100 mg, bid, 7 days

Drug: Doxycycline 14 days
Patient will be treated with doxycycline orally, 100 mg, bid, 14 days
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • erythema migrans in patients > 18 years

Exclusion Criteria:

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

Locations
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Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Investigators
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Principal Investigator: Daša Stupica, MD PhD University Medical Centre Ljubljana
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inflammatory Mediators in Erythema Migrans
Official Title  ICMJE Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Erythema Migrans
Intervention  ICMJE
  • Drug: Doxycycline 7 days
    Patient will be treated with doxycycline orally, 100 mg, bid, 7 days
  • Drug: Doxycycline 14 days
    Patient will be treated with doxycycline orally, 100 mg, bid, 14 days
Study Arms  ICMJE Experimental: erythema migrans patients treated with doxycycline
adult patients with erythema migrans will be treated with oral doxycycline
Interventions:
  • Drug: Doxycycline 7 days
  • Drug: Doxycycline 14 days
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 31, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • erythema migrans in patients > 18 years

Exclusion Criteria:

  • pregnancy or immunocompromising conditions
  • taking antibiotic with antiborrelial activity within 10 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956212
Other Study ID Numbers  ICMJE EM Doxy-2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daša Stupica, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE University of Ljubljana School of Medicine, Slovenia
Investigators  ICMJE
Principal Investigator: Daša Stupica, MD PhD University Medical Centre Ljubljana
PRS Account University Medical Centre Ljubljana
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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