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CompletedNCT03956212Updated Nov 3, 2020

Inflammatory Mediators in Erythema Migrans

An interventional study of Doxycycline 7 days and Doxycycline 14 days in Erythema Migrans, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-03.

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

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jun 2017, registered May 2019).
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

  • 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 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 immunocompromising conditions
  • 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 (actual)

Study arms

  • Experimental
    erythema migrans patients treated with doxycycline

    adult patients with erythema migrans will be treated with oral doxycycline

    Drug: Doxycycline 7 days · Drug: Doxycycline 14 days

Interventions

  • DrugDoxycycline 7 days

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

  • DrugDoxycycline 14 days

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

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

    Time frame: at enrollment

07

Study locations

1 site
  • University Medical Center Ljubljana
    Ljubljana, Slovenia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in Dec 2019, 30 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2019
First posted
May 20, 2019
StartActual
Jun 1, 2017
Primary completionActual
Dec 31, 2019
CompletionActual
Oct 31, 2020
Last update
Nov 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03956212
Collaborators
University of Ljubljana School of Medicine, Slovenia
Responsible party
Daša Stupica (Principal Investigator, University Medical Centre Ljubljana) — Principal investigator
First posted
May 20, 2019
Start date
Jun 1, 2017
Primary completion
Dec 31, 2019
Completion
Oct 31, 2020
Last update
Nov 3, 2020

Study contacts

Daša Stupica, MD PhD
principal investigator · University Medical Centre Ljubljana

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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