Patient's Pretreatment Expectations About Post-Lyme Symptoms

NCT ID: NCT03462329

Last Updated: 2025-03-28

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2027-12-01

Brief Summary

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The investigators will focus on pretreatment expectations of patients with early Lyme disease manifested as erythema migrans with the aim of assessing the association between pretreatment expectations quantified with a questionnaire and treatment outcome quantified with the presence of post-Lyme symptoms. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.

Detailed Description

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Conditions

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Erythema Migrans

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Patients will evaluate their pre-treatment expectations about treatment outcome of erythema migrans.

Nonspecific symptoms will be assessed in patients and control subjects.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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patients with erythema migrans

Patients will be treated with antibiotics for Lyme disease.

Group Type ACTIVE_COMPARATOR

Antibiotics (preferentially oral doxycycline 100 mg bid)

Intervention Type DRUG

Patients will be treated with antibiotics for Lyme disease.

controls

Control subjects will not be given antibiotics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antibiotics (preferentially oral doxycycline 100 mg bid)

Patients will be treated with antibiotics for Lyme disease.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* erythema migrans

Exclusion Criteria

* pregnancy or lactation
* immunocompromised
* taking 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 Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Daša Stupica

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical center Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Daša Stupica

Role: CONTACT

+38615222110

Maša Velušček

Role: CONTACT

+38615222110

Facility Contacts

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Daša Stupica, MD, PhD

Role: primary

+386 31 689 324

Maša Velušček, MD

Role: backup

+386 1 522 21 10

Other Identifiers

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Pretreatment expectations

Identifier Type: -

Identifier Source: org_study_id

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