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CompletedNCT03980015Updated Jun 11, 2019

Inflammatory Responses in Solitary and Multiple Erythema Migrans

An observational study 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 2019-06-11.

Sponsored by University Medical Centre Ljubljana · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
134
Ages
18 Years and older
Sex
All
01

Study summary

The investigators will evaluate differences in host immune responses (levels of cytokines and chemokines, representative of innate, Th1, and Th17 immune responses) in acute sera from adult patients with solitary or multiple erythema migrans.

02

Conditions studied

  • Erythema Migrans
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 134 is below the median of 245 across 12 observational 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
Sampling method
Non-probability sample

Study population

Adult patients with erythema migrans

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
  • Borrelia afzelii isolated from skin

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
134 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • erythema migrans

    patients with erythema migrans

    Other: antibiotic treatment

Interventions

  • Otherantibiotic treatment

    Patients were treated with: ceftriaxone intravenously 2 g OD for 14 days or doxycycline orally 100 mg bid for 10 to 14 days or cefuroxime axetil orally 500 mg bid for 14 days or amoxicillin orally 500 mg tid for 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 of patients at enrollment (during active infection).

    Time frame: at enrollment

07

Study locations

1 site
  • University Medical Centre Ljubljana
    Ljubljana, Slovenia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2006 to primary completion in Dec 2016, 126 months.

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

Registered
Jun 5, 2019
First posted
Jun 10, 2019
StartActual
Jun 1, 2006
Primary completionActual
Dec 31, 2016
CompletionActual
May 31, 2019
Last update
Jun 11, 2019
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 Jun 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03980015
Collaborators
University of Ljubljana School of Medicine, Slovenia
Responsible party
Daša Stupica (Prinicipal Investigator, University Medical Centre Ljubljana) — Principal investigator
First posted
Jun 10, 2019
Start date
Jun 1, 2006
Primary completion
Dec 31, 2016
Completion
May 31, 2019
Last update
Jun 11, 2019

Study contacts

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

Oversight

Data monitoring committee
No
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 Jun 2019. You cannot join it, but the record below documents what was studied.

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