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 : November 3, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erythema Migrans | Drug: Antibiotics (preferentially oral doxycycline 100 mg bid) | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: patients with erythema migrans
Patients will be treated with antibiotics for Lyme disease.
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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.
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- 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.
- 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.
- 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.
- 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.
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- erythema migrans
Exclusion Criteria:
- pregnancy or lactation
- immunocompromised
- taking antibiotic with antiborrelial activity within 10 days

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
Contact: Daša Stupica | +38615222110 | dasa.stupica@kclj.si | |
Contact: Maša Velušček | +38615222110 | masa.veluscek@kclj.si |
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 |
Responsible Party: | Daša Stupica, MD, PhD, University Medical Centre Ljubljana |
ClinicalTrials.gov Identifier: | NCT03462329 |
Other Study ID Numbers: |
Pretreatment expectations |
First Posted: | March 12, 2018 Key Record Dates |
Last Update Posted: | November 3, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Post-Lyme symptoms Pretreatment expectations |
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 Gram-Negative Bacterial Infections Bacterial Infections Spirochaetales Infections Infection Glossitis Anti-Bacterial Agents Doxycycline Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |