Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

NCT ID: NCT03966014

Last Updated: 2025-09-04

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

RECRUITING

Clinical Phase

NA

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2027-12-31

Brief Summary

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The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.

Detailed Description

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Conditions

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Erythema Migrans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EM-amoxicillin 3 x 10 days

Group Type ACTIVE_COMPARATOR

EM-amoxicillin 3 x 10 days

Intervention Type DRUG

Patients will receive amoxicillin 500 milligram tid for 10 days

EM-amoxicillin 3 x 14 days

Group Type ACTIVE_COMPARATOR

EM-amoxicillin 3 x 14 days

Intervention Type DRUG

Patients will receive amoxicillin 500 milligram tid for 14 days

EM-amoxicillin 2 x 14 days

Group Type ACTIVE_COMPARATOR

EM-amoxicillin 2 x 14 days

Intervention Type DRUG

Patients will receive amoxicillin 500 milligram bid for 14 days

Controls

Group Type OTHER

Controls

Intervention Type OTHER

No intervention.

Interventions

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EM-amoxicillin 3 x 10 days

Patients will receive amoxicillin 500 milligram tid for 10 days

Intervention Type DRUG

EM-amoxicillin 3 x 14 days

Patients will receive amoxicillin 500 milligram tid for 14 days

Intervention Type DRUG

EM-amoxicillin 2 x 14 days

Patients will receive amoxicillin 500 milligram bid for 14 days

Intervention Type DRUG

Controls

No intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* erythema migrans

Exclusion Criteria

* pregnancy
* extracutaneous manifestations of Lyme borreliosis
* immunocompromising state
* serious adverse event to beta lactam antibiotic
* receiving antibiotic with antiborrelial activity within 10 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia

Locations

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University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status NOT_YET_RECRUITING

Countries

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Slovenia

Central Contacts

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Daša Stupica, MD PhD

Role: CONTACT

+38631689324

Maša Velušček, MD

Role: CONTACT

+38631332904

Facility Contacts

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Daša Stupica, MD, PhD

Role: primary

+386 31 689 324

Maša Velušček, MD

Role: backup

+386 31 332 904

Daša Stupica, MD, PhD

Role: primary

+386 31 689 324

Maša Velušček, MD

Role: backup

+386 31 332 904

Other Identifiers

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Amoxy 10-15

Identifier Type: -

Identifier Source: org_study_id

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