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Status unknownNCT02147249Updated Apr 22, 2019

Cytokines and Chemokines in Erythema Migrans

An interventional study of antibiotic treatment in Erythema Migrans, sponsored by University Medical Centre Ljubljana. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-22.

Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Erythema Migrans

Keywords

  • erythema migrans
  • Lyme borreliosis
  • inflammation
  • outcome
03

In context

Glossitis, Benign Migratory

25 studies on the registry are indexed under Glossitis, Benign Migratory; 4 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 13 interventional studies indexed under Glossitis, Benign Migratory.

Browse Glossitis, Benign Migratory studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • erythema migrans in patients > 18 years

Exclusion criteria

Exclusion Criteria:

  • pregnancy or lactation
  • taking antibiotic with antiborrelial activity within 10 days
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    erythema migrans patients treated with antibiotics

    adult patients with erythema migrans will be treated with oral antibiotics

    Drug: antibiotic treatment

Interventions

  • Drugantibiotic 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

06

What researchers measure

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.

    Time frame: up to 12 months follow-up

Secondary outcomes

  1. gene polymorphisms in erythema migrans patients

    The expression of disease-relevant genomic variants will be assessed using ImmunoChip.

    Time frame: at enrollment

Other outcomes

  1. transcriptome profiles in erythema migrans patients

    We will use RNA sequencing of individual immune cell subtypes from patients to determine their transcriptome.

    Time frame: at 6 month follow-up

07

Study locations

1 of 1 sites recruiting
  • UMC Ljubljana, Department of Infectious Diseases
    Ljubljana, 1525, Slovenia
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02147249
Collaborators
University of Ljubljana School of Medicine, Slovenia, Medical University of Vienna, Harvard University
Responsible party
Franc Strle (MD, PhD, University Medical Centre Ljubljana) — Principal investigator
First posted
May 26, 2014
Start date
Jul 2013
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Apr 22, 2019

Study contacts

Dasa Stupica, MD,PhD
Contact
cerar.dasa@gmail.com
+386 1 5222110
Franc Strle, MD, PhD
Contact
franc.strle@kclj.si
+386 1 5222610
Franc Strle, MD, PhD
study chair · UMC Ljubljana
Dasa Stupica, MD, PhD
principal investigator · UMC Ljubljana

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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