Patient's Pretreatment Expectations About Post-Lyme Symptoms

Erythema Migrans Clinical Trial

Official title:

Impact of Patient's Pretreatment Expectations on Treatment Outcome of Early Lyme Borreliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03462329
• Other study ID #: Pretreatment expectations
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University Medical Centre Ljubljana
• Contact: Daša Stupica
• Phone: +38615222110
• Email: dasa.stupica[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• erythema migrans

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans
• Erythema Migrans

Intervention

Drug:
• Antibiotics (preferentially oral doxycycline 100 mg bid)
Patients will be treated with antibiotics for Lyme disease.

Locations

Country	Name	City	State
Slovenia	University Medical center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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	Patients will complete a written questionnaire asking whether they had had any of 8 nonspecific symptoms (fatigue, arthralgias, headache, myalgias, paresthesias, memory difficulties, concentration difficulties, irritability) within the preceding week. Control subjects will complete the same 8-symptom questionnaire as the patients within 14 days of the examination date of the corresponding patient at enrollment, and again at 6 and 12 months. Patients and controls will grade the severity of each individual symptom on a 10-cm visual analogue scale (10 = most severe).	Study points will be: at enrollment, at 6, and at 12 months post-enrollment.