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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Dermatophyte Species Distribution | To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatophyte Strain Types Among All Enrolled Households | Using southern blot analysis and RFLP to evaluate the isolates and strain types obtained from all enrolled households | Baseline |
| Number of Households With Dermatophyte Infection Spread |
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Inclusion Criteria: positive dermatophyte culture
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Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud A Ghannoum, PhD | Center for Medical Mycology, University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | One Infected Member | One infected member in multiple person household |
| FG001 | 2 or More Infected Members | Two or more infected members in a multiple person household |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Person Households | Households with at least 1 resident with tinea pedis and/or onychommycosis. |
| BG001 | Multiperson Households | Households with at least 2 residents and 1 individual with tinea pedis and /or onychommycosis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dermatophyte Species Distribution | To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR) | Posted | Number | isolates | Baseline | Households | Households |
|
|
Adverse Event data was not collection, this was a single clinic visit.
Averse Event data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multi Person Households | Households with at least 2 residents and 1 individual with tinea pedis and/or onychomycosis |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mahmoud Ghannoum | University Hospitals Cleveland Medical Center Center for Medical Mycology | 216-844-8580 | Mahmoud.Ghannoum@case.edu |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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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.
| Baseline |
| Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis | 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. | Baseline |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| Households |
|
|
| Secondary | Dermatophyte Strain Types Among All Enrolled Households | Using southern blot analysis and RFLP to evaluate the isolates and strain types obtained from all enrolled households | Posted | Number | isolates | Baseline | Households | Households |
|
|
|
| Secondary | Number of Households With Dermatophyte Infection Spread | 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. | This outcome measure was intended to identify the number of households with dermatophyte infection spread in multiple infected member households only. | Posted | Number | Households | Baseline | Households | Households |
|
|
|
| Secondary | Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis | 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. | Posted | Number | participants | Baseline | Households | Households |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Single Person Household | Households with 1 resident/individual with tinea pedis and/or onychomycosis | 0 | 0 | 0 | 0 | 0 | 0 |
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| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| E Floccosum strain types |
|
| Title | Measurements |
|---|---|
|