Patient's Pretreatment Expectations About Post-Lyme Symptoms

NCT03462329 | Recruiting

• 1 other identifier: Pretreatment expectations
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erythema Migrans

Keywords

Post-Lyme symptoms; Pretreatment expectations

Outcome Measures

Primary Outcomes (4)

• Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans

  At follow-up at 14 days patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms. Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis will be interpreted as failure.

  Study point: at 14 days post-enrollment.

• Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months postenrollment in patients treated for erythema migrans

  At follow-up at 2 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms. Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/ or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.

  Study point: at 2 months post-enrollment.

• Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months postenrollment in patients treated for erythema migrans

  At follow-up at 6 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms. Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/ or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.

  Study point: at 6 months post-enrollment.

• Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months postenrollment in patients treated for erythema migrans

  At 12 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms. Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/ or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.

  Study point: at 12 months post-enrollment.

Secondary Outcomes (1)

• Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with erythema migrans and control subjects

  Study points will be: at enrollment, at 6, and at 12 months post-enrollment.

Study Arms (2)

patients with erythema migrans

ACTIVE COMPARATOR

Patients will be treated with antibiotics for Lyme disease.

Drug: Antibiotics (preferentially oral doxycycline 100 mg bid)

controls

NO INTERVENTION

Control subjects will not be given antibiotics.

Interventions

Antibiotics (preferentially oral doxycycline 100 mg bid) DRUG

Patients will be treated with antibiotics for Lyme disease.

patients with erythema migrans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• erythema migrans

You may not qualify if:

• pregnancy or lactation
• immunocompromised
• taking antibiotic with antiborrelial activity within 10 days

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical center Ljubljana

Ljubljana, Slovenia

RECRUITING

MeSH Terms

Conditions

Glossitis, Benign Migratory

Interventions

Anti-Bacterial Agents; BID protein, human

Condition Hierarchy (Ancestors)

Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Daša Stupica

CONTACT

+38615222110; dasa.stupica@kclj.si

Maša Velušček

CONTACT

+38615222110; masa.veluscek@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Patients will evaluate their pre-treatment expectations about treatment outcome of erythema migrans. Nonspecific symptoms will be assessed in patients and control subjects.

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 12, 2018
• Study Start: June 1, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

SL (1)