NCT03980015

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

10.6 years

First QC Date

June 5, 2019

Last Update Submit

June 6, 2019

Conditions

Erythema Migrans

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 of patients at enrollment (during active infection).

    at enrollment

Study Arms (1)

erythema migrans

patients with erythema migrans

Other: antibiotic treatment

Interventions

antibiotic treatmentOTHER

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

erythema migrans

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with erythema migrans

You may qualify if:

  • erythema migrans in patients \> 18 years
  • Borrelia afzelii isolated from skin

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Glossitis, Benign Migratory

Condition Hierarchy (Ancestors)

GlossitisTongue DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Daša Stupica, MD PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 10, 2019

Study Start

June 1, 2006

Primary Completion

December 31, 2016

Study Completion

May 31, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Locations

SL(1)