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Recruiting NCT03462329

Patient's Pretreatment Expectations About Post-Lyme Symptoms

No phase Interventional Erythema Migrans

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antibiotics (preferentially oral doxycycline 100 mg bid).
Who it may be relevant to
Registry conditions: Erythema Migrans. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Study point: at 12 months post-enrollment.]
Secondary outcome measures (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 [Time frame: Study points will be: at enrollment, at 6, and at 12 months post-enrollment.]

Eligibility criteria

Inclusion criteria

  • erythema migrans

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Slovenia · 1 center
  • University Medical center Ljubljana — Ljubljana

Identifiers

NCT: NCT03462329 · Pretreatment expectations

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗