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Trial record 38 of 64 for:    lyme

Cytokines and Chemokines in Erythema Migrans

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ClinicalTrials.gov Identifier: NCT02147249
Recruitment Status : Recruiting
First Posted : May 26, 2014
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

June 24, 2013
May 26, 2014
May 5, 2017
July 2013
December 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02147249 on ClinicalTrials.gov Archive Site
gene polymorphisms in erythema migrans patients [ Time Frame: at enrollment ]
The expression of disease-relevant genomic variants will be assessed using ImmunoChip.
Same as current
transcriptome profiles in erythema migrans patients [ Time Frame: at 6 month follow-up ]
We will use RNA sequencing of individual immune cell subtypes from patients to determine their transcriptome.
Same as current
 
Cytokines and Chemokines in Erythema Migrans
Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With 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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Erythema Migrans
Drug: antibiotic treatment
Patient will be treated with: doxycycline orally, 100 mg, bid, 14 days or cefuroxime axetil orally, 500 mg, bid, 14 days or amoxicillin orally, 500 mg, tid, 14 days
Experimental: erythema migrans patients treated with antibiotics
adult patients with erythema migrans will be treated with oral antibiotics
Intervention: Drug: antibiotic treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • erythema migrans in patients > 18 years

Exclusion Criteria:

  • pregnancy or lactation
  • taking antibiotic with antiborrelial activity within 10 days
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Dasa Stupica, MD,PhD +386 1 5222110 cerar.dasa@gmail.com
Contact: Franc Strle, MD, PhD +386 1 5222610 franc.strle@kclj.si
Slovenia
 
 
NCT02147249
EM-0613
No
Not Provided
Not Provided
Franc Strle, University Medical Centre Ljubljana
University Medical Centre Ljubljana
  • University of Ljubljana School of Medicine, Slovenia
  • Medical University of Vienna
  • Harvard University
Study Chair: Franc Strle, MD, PhD UMC Ljubljana
Principal Investigator: Dasa Stupica, MD, PhD UMC Ljubljana
University Medical Centre Ljubljana
May 2017

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