[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100321243":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":38,"interventions":49,"overallOfficials":30,"centralContacts":54,"locations":63,"responsibleParty":83,"collaborators":30,"id":86,"slug":30,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":30,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":30,"enrollmentInfo":95,"targetDuration":30,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":66,"whyStopped":30,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":30},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"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.\n\nComplete 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.",{"measure":14,"description":15,"timeFrame":16},"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.\n\nComplete 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\u002F or persistence of borreliae as detected by culture of skin re-biopsy sample, and\u002For persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.","Study point: at 2 months post-enrollment.",{"measure":18,"description":19,"timeFrame":20},"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.\n\nComplete 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\u002F or persistence of borreliae as detected by culture of skin re-biopsy sample, and\u002For persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.","Study point: at 6 months post-enrollment.",{"measure":22,"description":23,"timeFrame":24},"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.\n\nSymptoms 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\u002F or persistence of borreliae as detected by culture of skin re-biopsy sample, and\u002For persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.","Study point: at 12 months post-enrollment.",[26],{"measure":27,"description":28,"timeFrame":29},"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.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"NON_RANDOMIZED","SINGLE_GROUP","Patients will evaluate their pre-treatment expectations about treatment outcome of erythema migrans.\n\nNonspecific symptoms will be assessed in patients and control subjects.","BASIC_SCIENCE",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"patients with erythema migrans","ACTIVE_COMPARATOR","Patients will be treated with antibiotics for Lyme disease.",[44],"Drug: Antibiotics (preferentially oral doxycycline 100 mg bid)",{"label":46,"type":47,"description":48,"interventionNames":30},"controls","NO_INTERVENTION","Control subjects will not be given antibiotics.",[50],{"type":51,"name":52,"description":42,"armGroupLabels":53,"otherNames":30},"DRUG","Antibiotics (preferentially oral doxycycline 100 mg bid)",[40],[55,60],{"name":56,"role":57,"phone":58,"phoneExt":30,"email":59},"Daša Stupica","CONTACT","+38615222110","dasa.stupica@kclj.si",{"name":61,"role":57,"phone":58,"phoneExt":30,"email":62},"Maša Velušček","masa.veluscek@kclj.si",[64],{"facility":65,"status":66,"city":67,"state":30,"zip":30,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"University Medical center Ljubljana","RECRUITING","Ljubljana","Slovenia","SI",{"type":71,"coordinates":72},"Point",[73,74],14.50513,46.05108,{"lat":74,"lon":73},[77,80],{"name":78,"role":57,"phone":79,"phoneExt":30,"email":59},"Daša Stupica, MD, PhD","+386 31 689 324",{"name":81,"role":57,"phone":82,"phoneExt":30,"email":62},"Maša Velušček, MD","+386 1 522 21 10",{"type":84,"investigatorFullName":56,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","MD, PhD","100321243",false,"NCT03462329","Patient's Pretreatment Expectations About Post-Lyme Symptoms","Impact of Patient's Pretreatment Expectations on Treatment Outcome of Early Lyme Borreliosis","Inclusion Criteria:\n\n* erythema migrans\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* immunocompromised\n* taking antibiotic with antiborrelial activity within 10 days",true,"ALL","18 Years",{"count":96,"type":97},200,"ESTIMATED","INTERVENTIONAL",[100],"NA","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.",[103],"Erythema Migrans",[105,106],"Post-Lyme symptoms","Pretreatment expectations","2026-04-27",{"date":109,"type":110},"2026-04-29","ACTUAL",{"date":112,"type":110},"2018-06-01",{"date":114,"type":97},"2028-12-01",{"name":5,"class":6},1]