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Patient's Pretreatment Expectations About Post-Lyme Symptoms

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ClinicalTrials.gov Identifier: NCT03462329
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Daša Stupica, University Medical Centre Ljubljana

Study Description
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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.

Condition or disease Intervention/treatment Phase
Erythema Migrans Drug: Antibiotics (preferentially oral doxycycline 100 mg bid) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

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

Nonspecific symptoms will be assessed in patients and control subjects.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Patient's Pretreatment Expectations on Treatment Outcome of Early Lyme Borreliosis
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease
Drug Information available for: Doxycycline

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: patients with erythema migrans
Patients will be treated with antibiotics for Lyme disease.
 Drug: Antibiotics (preferentially oral doxycycline 100 mg bid)
Patients will be treated with antibiotics for Lyme disease.
No Intervention: controls
Control subjects will not be given antibiotics.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

    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.


  2. 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. ]

    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.


  3. 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. ]

    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.


  4. 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. ]

    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.



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. ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • erythema migrans

Exclusion Criteria:

  • pregnancy or lactation
  • immunocompromised
  • taking antibiotic with antiborrelial activity within 10 days
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462329


Contacts
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Contact: Daša Stupica +38615222110 dasa.stupica@kclj.si
Contact: Maša Velušček +38615222110 masa.veluscek@kclj.si

Locations
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Slovenia
University Medical center Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Daša Stupica, MD, PhD    +386 31 689 324    dasa.stupica@kclj.si   
Contact: Maša Velušček, MD    +386 1 522 21 10    masa.veluscek@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
More Information
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Responsible Party: Daša Stupica, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03462329     History of Changes
Other Study ID Numbers: Pretreatment expectations
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daša Stupica, University Medical Centre Ljubljana:
Post-Lyme symptoms
Pretreatment expectations
Additional relevant MeSH terms:
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Skin Diseases
Lyme Disease
Borrelia Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Erythema
Skin Manifestations
Signs and Symptoms
 Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Infection
Glossitis
Anti-Bacterial Agents
Doxycycline
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents