Inflammatory Responses in Solitary and Multiple Erythema Migrans

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Completed

CT.gov ID

NCT03980015

Collaborator

University of Ljubljana School of Medicine, Slovenia (Other)

134

Enrollment

Location

156

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erythema Migrans	Other: antibiotic treatment

Study Design

Study Type:

Observational

Actual Enrollment :

134 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Inflammatory Responses in Borrelia Afzelii Culture Positive Patients With Early Disseminated or Early Localized Lyme Borreliosis

Actual Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
erythema migrans patients with erythema migrans	Other: antibiotic 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

Arm

Intervention/Treatment

erythema migrans

patients with erythema migrans

Other: antibiotic 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

Outcome Measures

Primary Outcome Measures

inflammatory proteins in erythema migrans patients [at enrollment]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Centre Ljubljana	Ljubljana		Slovenia

Sponsors and Collaborators

University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia

Investigators

Principal Investigator: Daša Stupica, MD PhD, University Medical Centre Ljubljana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daša Stupica, Prinicipal Investigator, University Medical Centre Ljubljana

ClinicalTrials.gov Identifier:

NCT03980015

Other Study ID Numbers:

MEM vs EM cyto

First Posted:

Jun 10, 2019

Last Update Posted:

Jun 11, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Erythema Chronicum Migrans

Glossitis, Benign Migratory

Erythema

Anti-Bacterial Agents

Study Results

No Results Posted as of Jun 11, 2019