[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100359893":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":24,"interventions":41,"overallOfficials":56,"centralContacts":61,"locations":70,"responsibleParty":96,"collaborators":99,"id":102,"slug":17,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":17,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":17,"enrollmentInfo":111,"targetDuration":17,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":17,"overallStatus":72,"whyStopped":17,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated\u002Fpost-Lyme borreliosis symptoms","At each visit physical examination wil be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for and documented. At each visit patients will be asked an open question about any health-related symptoms that had newly developed or worsened since the onset of erythema migrans. If these symptoms will have no other known medical explanation, they will be regarded as Lyme borreliosis-associated constitutional symptoms at enrolment or post-Lyme borreliosis symptoms at follow-up.","One year follow-up",[14],{"measure":15,"description":16,"timeFrame":12},"Number (frequency) of patients with nonspecific symptoms","At each visit patients will be asked to complete a written questionnaire asking whether they had had any of eight non-specific symptoms (fatigue, arthralgias, headache,myalgias, paraesthesias, memory difficulties, concentration difficulties and irritability) within the preceding week.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE",[25,31,36],{"label":26,"type":27,"description":28,"interventionNames":29},"EM-amoxicillin 3 x 10 days","ACTIVE_COMPARATOR","amoxicillin for 10 days",[30],"Drug: EM-amoxicillin 3 x 10 days",{"label":32,"type":27,"description":33,"interventionNames":34},"EM-amoxicillin 3 x 14 days","amoxicillin for 14 days",[35],"Drug: EM-amoxicillin 3 x 14 days",{"label":37,"type":6,"description":38,"interventionNames":39},"Controls","controls without Lyme borreliosis",[40],"Other: Controls",[42,48,53],{"type":43,"name":26,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Patients will receive amoxicillin 500 milligram tid for 10 days",[26],[47],"10 days",{"type":43,"name":32,"description":49,"armGroupLabels":50,"otherNames":51},"Patients will receive amoxicillin 500 milligram tid for 14 days",[32],[52],"14 days",{"type":6,"name":37,"description":54,"armGroupLabels":55,"otherNames":17},"No intervention.",[37],[57],{"name":58,"affiliation":59,"role":60},"Daša Stupica, MD PhD","Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia","PRINCIPAL_INVESTIGATOR",[62,66],{"name":58,"role":63,"phone":64,"phoneExt":17,"email":65},"CONTACT","+38631689324","dasa.stupica@kclj.si",{"name":67,"role":63,"phone":68,"phoneExt":17,"email":69},"Maša Velušček, MD","+38631332904","masa.veluscek@kclj.si",[71,88],{"facility":5,"status":72,"city":73,"state":17,"zip":17,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"RECRUITING","Ljubljana","Slovenia","SI",{"type":77,"coordinates":78},"Point",[79,80],14.50513,46.05108,{"lat":80,"lon":79},[83,86],{"name":84,"role":63,"phone":85,"phoneExt":17,"email":65},"Daša Stupica, MD, PhD","+386 31 689 324",{"name":67,"role":63,"phone":87,"phoneExt":17,"email":69},"+386 31 332 904",{"facility":5,"status":89,"city":73,"state":17,"zip":17,"country":74,"countryCode":75,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"NOT_YET_RECRUITING",{"type":77,"coordinates":91},[79,80],{"lat":80,"lon":79},[94,95],{"name":84,"role":63,"phone":85,"phoneExt":17,"email":65},{"name":67,"role":63,"phone":87,"phoneExt":17,"email":69},{"type":60,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Daša Stupica","Principal Investigator",[100],{"name":101,"class":6},"University of Ljubljana School of Medicine, Slovenia","100359893",false,"NCT03966014","Different Amoxicillin Treatment Regimens in Erythema Migrans Patients","Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.","Inclusion Criteria:\n\n* erythema migrans\n\nExclusion Criteria:\n\n* pregnancy\n* extracutaneous manifestations of Lyme borreliosis\n* immunocompromising state\n* serious adverse event to beta lactam antibiotic\n* receiving antibiotic with antiborrelial activity within 10 days",true,"ALL","18 Years",{"count":112,"type":113},200,"ESTIMATED","INTERVENTIONAL",[116],"PHASE3","The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.",[119],"Erythema Migrans","2026-03-22",{"date":122,"type":123},"2026-03-25","ACTUAL",{"date":125,"type":123},"2019-06-01",{"date":127,"type":113},"2027-12-31",{"name":5,"class":6},2]