Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-03 @ 9:15 PM
Study NCT ID:
NCT03337932
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2017-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duration of Doxycycline Treatment in MEM Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015787', 'term': 'Erythema Chronicum Migrans'}], 'ancestors': [{'id': 'D008193', 'term': 'Lyme Disease'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D004890', 'term': 'Erythema'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days', 'timeFrame': 'Study point: at 14 days post-enrollment.', 'description': '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 the multiple 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.'}, {'measure': 'Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days', 'timeFrame': 'Study point: at 2 months post-enrollment.', 'description': '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 the multiple 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/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.'}, {'measure': 'Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days', 'timeFrame': 'Study point: at 6 months post-enrollment.', 'description': '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 the multiple 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/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.'}, {'measure': 'Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days', 'timeFrame': 'Study point: at 12 months post-enrollment.', 'description': '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 the multiple 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/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.'}], 'secondaryOutcomes': [{'measure': 'Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with multiple erythema migrans and control subjects', 'timeFrame': 'Study points will be: at enrollment, at 6, and at 12 months post-enrollment.', 'description': '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.\n\nControl 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.\n\nPatients and controls will grade the severity of each individual symptom on a 10-cm visual analogue scale (10 = most severe).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erythema Chronicum Migrans']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• multiple erythema migrans\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* immunocompromised\n* serious adverse event to doxycycline\n* taking antibiotic with antiborrelial activity within 10 days\n* extracutaneous manifestations of lyme borreliosis'}, 'identificationModule': {'nctId': 'NCT03337932', 'briefTitle': 'Duration of Doxycycline Treatment in MEM Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Duration of Doxycycline Treatment in Patients With Multiple Erythema Migrans (MEM). A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MEM-Doxy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MEM-7 days doxycycline', 'interventionNames': ['Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MEM-14 days doxycycline', 'interventionNames': ['Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Controls', 'interventionNames': ['Drug: Controls without a history of lyme disease.']}], 'interventions': [{'name': 'Doxycycline 100 milligram Oral Tablet bid, 7 days', 'type': 'DRUG', 'description': 'Patients will receive doxycycline for 7 days.', 'armGroupLabels': ['MEM-7 days doxycycline']}, {'name': 'Doxycycline 100 milligram Oral Tablet bid, 14 days', 'type': 'DRUG', 'description': 'Patients will receive doxycycline for 14 days.', 'armGroupLabels': ['MEM-14 days doxycycline']}, {'name': 'Controls without a history of lyme disease.', 'type': 'DRUG', 'description': 'No intervention.', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Daša Stupica, MD, PhD', 'role': 'CONTACT', 'email': 'dasa.stupica@kclj.si', 'phone': '+386 31 689 324'}, {'name': 'Maša Velušček, MD', 'role': 'CONTACT', 'email': 'masa.veluscek@kclj.si', 'phone': '+386 1 522 21 10'}], 'facility': 'University Medical center Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Daša Stupica, MD, PhD', 'role': 'CONTACT', 'email': 'dasa.stupica@kclj.si', 'phone': '+386 31 689 324'}, {'name': 'Maša Velušček, MD', 'role': 'CONTACT', 'email': 'masa.veluscek@kclj.si', 'phone': '+386 1 522 21 10'}], 'overallOfficials': [{'name': 'Daša Stupica, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Ljubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daša Stupica', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}