Cytokines and Chemokines in Erythema Migrans
Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedApril 22, 2019
April 1, 2019
7.5 years
June 24, 2013
April 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
inflammatory proteins in erythema migrans patients
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.
up to 12 months follow-up
Secondary Outcomes (1)
gene polymorphisms in erythema migrans patients
at enrollment
Other Outcomes (1)
transcriptome profiles in erythema migrans patients
at 6 month follow-up
Study Arms (1)
erythema migrans patients treated with antibiotics
EXPERIMENTALadult patients with erythema migrans will be treated with oral antibiotics
Interventions
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
Eligibility Criteria
You may qualify if:
- erythema migrans in patients \> 18 years
You may not qualify if:
- pregnancy or lactation
- taking antibiotic with antiborrelial activity within 10 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Centre Ljubljanalead
- University of Ljubljana School of Medicine, Sloveniacollaborator
- Medical University of Viennacollaborator
- Harvard Universitycollaborator
Study Sites (1)
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1525, Slovenia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Franc Strle, MD, PhD
UMC Ljubljana
- PRINCIPAL INVESTIGATOR
Dasa Stupica, MD, PhD
UMC Ljubljana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 24, 2013
First Posted
May 26, 2014
Study Start
July 1, 2013
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
April 22, 2019
Record last verified: 2019-04