Inflammatory Mediators in Erythema Migrans

NCT ID: NCT03956212

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erythema Migrans

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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erythema migrans patients treated with doxycycline

adult patients with erythema migrans will be treated with oral doxycycline

Group Type EXPERIMENTAL

Doxycycline 7 days

Intervention Type DRUG

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

Doxycycline 14 days

Intervention Type DRUG

Patient will be treated with doxycycline orally, 100 mg, bid, 14 days

Interventions

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Doxycycline 7 days

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

Intervention Type DRUG

Doxycycline 14 days

Patient will be treated with doxycycline orally, 100 mg, bid, 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* erythema migrans in patients \> 18 years

Exclusion Criteria

* pregnancy or immunocompromising conditions
* taking antibiotic with antiborrelial activity within 10 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana School of Medicine, Slovenia

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Daša Stupica

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daša Stupica, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

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University Medical Center Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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EM Doxy-2017

Identifier Type: -

Identifier Source: org_study_id