Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-25 @ 5:22 PM
Study NCT ID:
NCT03153267
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duration of Doxycycline Treatment in EM 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2017-05-12', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days', 'timeFrame': 'At 12 months after enrollment.', 'description': 'Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.'}], 'secondaryOutcomes': [{'measure': 'Comparison of nonspecific symptoms in patients with erythema migrans and control subjects', 'timeFrame': 'At 12 months after enrollment.', 'description': 'Number of patients after treatment with doxycycline for 7 or 14 days for erythema migrans and number of control subjects (without a history o Lyme borreliosis) with nonspecific symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erythema Chronicum Migrans']}, 'referencesModule': {'references': [{'pmid': '36209759', 'type': 'DERIVED', 'citation': 'Stupica D, Collinet-Adler S, Blagus R, Gomiscek A, Cerar Kisek T, Ruzic-Sabljic E, Veluscek M. Treatment of erythema migrans with doxycycline for 7 days versus 14 days in Slovenia: a randomised open-label non-inferiority trial. Lancet Infect Dis. 2023 Mar;23(3):371-379. doi: 10.1016/S1473-3099(22)00528-X. Epub 2022 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with erythema migrans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* solitary 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* multiple erythema migrans or extracutaneous manifestations of lyme borreliosis'}, 'identificationModule': {'nctId': 'NCT03153267', 'briefTitle': 'Duration of Doxycycline Treatment in EM Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'EM-Doxy714'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EM-7 days doxycycline', 'interventionNames': ['Drug: Doxycycline 100 MG Oral Tablet bid, 7 days']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EM-14 days doxycycline', 'interventionNames': ['Drug: Doxycycline 100 MG Oral Tablet bid, 14 days']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Controls', 'interventionNames': ['Drug: Controls without a history of lyme disease.']}], 'interventions': [{'name': 'Doxycycline 100 MG Oral Tablet bid, 7 days', 'type': 'DRUG', 'description': 'Patients will receive doxycycline for 7 days.', 'armGroupLabels': ['EM-7 days doxycycline']}, {'name': 'Doxycycline 100 MG Oral Tablet bid, 14 days', 'type': 'DRUG', 'description': 'Patients will receive doxycycline for 14 days.', 'armGroupLabels': ['EM-14 days doxycycline']}, {'name': 'Controls without a history of lyme disease.', 'type': 'DRUG', 'description': 'No intervention.', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical centzer Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Daša Stupica, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Mecical Centre Ljubljana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ljubljana School of Medicine, Slovenia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Daša Stupica', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}