Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT00233493
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2005-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Spread of Dermatophytes Among Families
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014009', 'term': 'Onychomycosis'}, {'id': 'D014008', 'term': 'Tinea Pedis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'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': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005533', 'term': 'Foot Dermatoses'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Mahmoud.Ghannoum@case.edu', 'phone': '216-844-8580', 'title': 'Dr. Mahmoud Ghannoum', 'organization': 'University Hospitals Cleveland Medical Center Center for Medical Mycology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A cross-sectional, not longitudinal, analysis; therefore, we were unable to determine the chronology of infection, the cause-and-effect relationship between specific strain types and infection, or the household member that was infected first.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data was not collection, this was a single clinic visit.', 'description': 'Averse Event data was not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Multi Person Households', 'description': 'Households with at least 2 residents and 1 individual with tinea pedis and/or onychomycosis', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Single Person Household', 'description': 'Households with 1 resident/individual with tinea pedis and/or onychomycosis', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dermatophyte Species Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Households', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SIM Households', 'description': 'SIM Households in which dermatophyte isolates were isolated'}, {'id': 'OG001', 'title': 'MIM Households', 'description': 'MIM Households in which dermatophyte isolates were identified'}], 'classes': [{'title': 'T Rubrum Isolates', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'T Mentagrophytes Isolates', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'E Floccosum Isolates', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR)', 'unitOfMeasure': 'isolates', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Households', 'denomUnitsSelected': 'Households'}, {'type': 'SECONDARY', 'title': 'Dermatophyte Strain Types Among All Enrolled Households', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Households', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SIM Households', 'description': 'Isolates obtained from SIM households'}, {'id': 'OG001', 'title': 'MIM Households', 'description': 'Isolates obtained from MIM households'}], 'classes': [{'title': 'T rubrum strain type', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'T mentagrophytes strain types', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'E Floccosum strain types', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Using southern blot analysis and RFLP to evaluate the isolates and strain types obtained from all enrolled households', 'unitOfMeasure': 'isolates', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Households', 'denomUnitsSelected': 'Households'}, {'type': 'SECONDARY', 'title': 'Number of Households With Dermatophyte Infection Spread', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'Households', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIM Household', 'description': 'Number of households associated with spread of infection associated with specific strain types'}], 'classes': [{'title': 'Spread of Infection due to T Rubrum Isolates', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Spread of Infection due to T Mentagrophytes Isolates', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No Spread of Infection', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'To determine if dermatophyte infection in household members could spread to other members, we analyzed the Southern blot and RFLP band patterns for different clinical isolates obtained from members residing in the same MIM households.', 'unitOfMeasure': 'Households', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Households', 'denomUnitsSelected': 'Households', 'populationDescription': 'This outcome measure was intended to identify the number of households with dermatophyte infection spread in multiple infected member households only.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Households', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIM Household', 'description': 'Host associated factors and spread of infection among individuals residing in the same household'}, {'id': 'OG001', 'title': 'SIM Household', 'description': 'Host associated factors and spread of infection among individuals residing in the same household'}], 'classes': [{'title': 'Spread of Infection and history of tinea pedis or onychomycosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Spread of Infection and history of both tinea pedis and onychomycosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The relationship between spread of infection and whether a subject previously had onychomycosis, tinea pedis, or onychomycosis plus tinea pedis was investigated. We collected how many subjects had spread of infection and onychomycosis alone, or spread of infection and tinea pedis alone, as well as how many subjects had spread of infection and onychomycosis plus tinea pedis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Households', 'denomUnitsSelected': 'Households'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'One Infected Member', 'description': 'One infected member in multiple person household'}, {'id': 'FG001', 'title': '2 or More Infected Members', 'description': 'Two or more infected members in a multiple person household'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '32', 'numSubjects': '32'}, {'groupId': 'FG001', 'numUnits': '18', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '32', 'numSubjects': '32'}, {'groupId': 'FG001', 'numUnits': '18', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Households'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Person Households', 'description': 'Households with at least 1 resident with tinea pedis and/or onychommycosis.'}, {'id': 'BG001', 'title': 'Multiperson Households', 'description': 'Households with at least 2 residents and 1 individual with tinea pedis and /or onychommycosis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.73', 'spread': '17.61', 'groupId': 'BG000'}, {'value': '50.33', 'spread': '20.80', 'groupId': 'BG001'}, {'value': '54.03', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2005-10-03', 'resultsFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-15', 'studyFirstPostDateStruct': {'date': '2005-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dermatophyte Species Distribution', 'timeFrame': 'Baseline', 'description': 'To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR)'}], 'secondaryOutcomes': [{'measure': 'Dermatophyte Strain Types Among All Enrolled Households', 'timeFrame': 'Baseline', 'description': 'Using southern blot analysis and RFLP to evaluate the isolates and strain types obtained from all enrolled households'}, {'measure': 'Number of Households With Dermatophyte Infection Spread', 'timeFrame': 'Baseline', 'description': 'To determine if dermatophyte infection in household members could spread to other members, we analyzed the Southern blot and RFLP band patterns for different clinical isolates obtained from members residing in the same MIM households.'}, {'measure': 'Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis', 'timeFrame': 'Baseline', 'description': 'The relationship between spread of infection and whether a subject previously had onychomycosis, tinea pedis, or onychomycosis plus tinea pedis was investigated. We collected how many subjects had spread of infection and onychomycosis alone, or spread of infection and tinea pedis alone, as well as how many subjects had spread of infection and onychomycosis plus tinea pedis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dermatophytes'], 'conditions': ['Onychomycosis', 'Tinea Pedis']}, 'descriptionModule': {'briefSummary': 'The objective is to demonstrate person-to-person spread of dermatophytes of the skin and nails among family members, as measured by fungal culture and DNA typing of the dermatophytes isolated.', 'detailedDescription': 'Enrolled families consist of at least two members over the age of 14. Once the index person is examined and a dermatophyte is isolated from either toenail or foot scale, other family members are examined and cultured. All dermatophyte isolates obtained from each family unit are compared using DNA typing and restriction length polymorphism (RFLP) to determine whether family members share the same organism or were infected by an outside source.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study Design-Households with at least 2 residents and 1 individual (index person \\[IP\\]) with tinea pedis and/or onychomycosis were identified by screening. Infection was confirmed clinically and mycologically (potassium hydroxide \\[KOH\\] and culture positive) in the IP; then other members within the same household were examined for tinea pedis and/or onychomycosis using the same criteria. All participants with confirmed fungal infections were referred to their primary care physicians for appropriate treatment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: positive dermatophyte culture\n\n\\-\n\nExclusion Criteria:\n\n* use of antifungal agents, either oral or topical'}, 'identificationModule': {'nctId': 'NCT00233493', 'briefTitle': 'Spread of Dermatophytes Among Families', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Demonstration of the Spread of Dermatophytes Through Casual Contact Among Family Household Members', 'orgStudyIdInfo': {'id': 'CSFO327KUS16'}}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Mahmoud A Ghannoum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Medical Mycology, University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}