Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-02 @ 12:02 AM
Study NCT ID:
NCT02714504
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anti-mold Azole in the Prophylaxis for Invasive Fusariosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060585', 'term': 'Fusariosis'}, {'id': 'D014009', 'term': 'Onychomycosis'}], 'ancestors': [{'id': 'D060605', 'term': 'Hyalohyphomycosis'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014005', 'term': 'Tinea'}, {'id': 'D009260', 'term': 'Nail Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065819', 'term': 'Voriconazole'}, {'id': 'C101425', 'term': 'posaconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mnucci@hucff.ufrj.br', 'phone': '552139382463', 'title': 'Dr Marcio Nucci', 'organization': 'Univ Fed Rio de Janeiro'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Observational', 'description': 'No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Anti-mold Prophylaxis', 'description': 'Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.\n\nVoriconazole or posaconazole: Azole with activity against molds', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 0, 'seriousNumAtRisk': 178, 'deathsNumAffected': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational', 'description': 'No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions'}, {'id': 'OG001', 'title': 'Anti-mold Prophylaxis', 'description': 'Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.\n\nVoriconazole or posaconazole: Azole with activity against molds'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until neutrophil recovery, for an average of 4 weeks', 'description': 'Proportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Observational', 'description': 'No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions'}, {'id': 'FG001', 'title': 'Anti-mold Prophylaxis', 'description': 'Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.\n\nVoriconazole or posaconazole: Azole with activity against molds'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Observational', 'description': 'No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions'}, {'id': 'BG001', 'title': 'Anti-mold Prophylaxis', 'description': 'Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.\n\nVoriconazole or posaconazole: Azole with activity against molds'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '66'}, {'value': '50', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '72'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '13', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2016-03-08', 'resultsFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2016-03-18', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-23', 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery', 'timeFrame': 'Until neutrophil recovery, for an average of 4 weeks', 'description': 'Proportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prophylaxis'], 'conditions': ['Fusariosis', 'Onychomycosis']}, 'descriptionModule': {'briefSummary': 'Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened with dermatologic examination. In the presence of any skin lesion in the extremities, direct exam and fungal culture will be performed. If these exams indicate the presence of Fusarium species, patients will receive anti-mold azole prophylaxis', 'detailedDescription': 'Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened on admission. Patients may be included more than once, provided that a new treatment is administered and \\>30 days elapses from one to other admission (episode).\n\nScreening will consist of a thorough physical examination in the extremities. In case of a skin lesion, direct exam and fungal culture will be performed. Nail samples will be obtained by scrapping the nails with a curette, and samples from interdigital areas will be obtained using swabs.\n\nIn a first phase no intervention will be performed. In a second phase, if direct exam and /or culture indicate the presence of Fusarium spp., primary antifungal therapy with an anti-mold azole (voriconazole (200 mg BID) or posaconazole (200 mg TID) will be started.\n\nPatients will be followed until discharge. The primary endpoint is invasive fusariosis, comparing the observational period with the intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admission for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia\n\nExclusion Criteria:\n\n* prior documentation of invasive fusariosis or allergy to azoles'}, 'identificationModule': {'nctId': 'NCT02714504', 'acronym': 'Fusarproph', 'briefTitle': 'Anti-mold Azole in the Prophylaxis for Invasive Fusariosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Evaluation of the Efficacy of Anti-mold Azole Prophylaxis in High-risk Hematologic Patients With Baseline Superficial Skin Lesions Positive for Fusarium Spp', 'orgStudyIdInfo': {'id': 'Fusarium prophylaxis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'observational', 'description': 'No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions'}, {'type': 'EXPERIMENTAL', 'label': 'Anti-mold prophylaxis', 'description': 'Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.', 'interventionNames': ['Drug: Voriconazole or posaconazole']}], 'interventions': [{'name': 'Voriconazole or posaconazole', 'type': 'DRUG', 'description': 'Azole with activity against molds', 'armGroupLabels': ['Anti-mold prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21941913', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Federal University of Rio de Janeiro', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marcio Nucci', 'investigatorAffiliation': 'Universidade Federal do Rio de Janeiro'}}}}