Onychomycosis, Tinea Pedis
Conditions
Keywords
dermatophytes
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
University Hospitals Cleveland Medical Center
Study design
Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
positive dermatophyte culture \-
Exclusion criteria
* use of antifungal agents, either oral or topical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermatophyte Species Distribution | Baseline | To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatophyte Strain Types Among All Enrolled Households | Baseline | Using southern blot analysis and RFLP to evaluate the isolates and strain types obtained from all enrolled households |
| Number of Households With Dermatophyte Infection Spread | Baseline | 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. |
| Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Person Households Households with at least 1 resident with tinea pedis and/or onychommycosis. | 32 |
| Multiperson Households Households with at least 2 residents and 1 individual with tinea pedis and /or onychommycosis. | 18 |
| Total | 50 |
Baseline characteristics
| Characteristic | Single Person Households | Multiperson Households | Total |
|---|---|---|---|
| Age, Continuous | 57.73 Years STANDARD_DEVIATION 17.61 | 50.33 Years STANDARD_DEVIATION 20.8 | 54.03 Years STANDARD_DEVIATION 3.7 |
| Region of Enrollment United States | 32 participants | 18 participants | 50 participants |
| Sex: Female, Male Female | 27 Participants | 6 Participants | 33 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Dermatophyte Species Distribution
To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIM Households | Dermatophyte Species Distribution | T Rubrum Isolates | 50 isolates |
| SIM Households | Dermatophyte Species Distribution | T Mentagrophytes Isolates | 5 isolates |
| SIM Households | Dermatophyte Species Distribution | E Floccosum Isolates | 2 isolates |
| MIM Households | Dermatophyte Species Distribution | T Rubrum Isolates | 37 isolates |
| MIM Households | Dermatophyte Species Distribution | T Mentagrophytes Isolates | 12 isolates |
| MIM Households | Dermatophyte Species Distribution | E Floccosum Isolates | 1 isolates |
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIM Households | Dermatophyte Strain Types Among All Enrolled Households | T rubrum strain type | 50 isolates |
| SIM Households | Dermatophyte Strain Types Among All Enrolled Households | T mentagrophytes strain types | 5 isolates |
| SIM Households | Dermatophyte Strain Types Among All Enrolled Households | E Floccosum strain types | 2 isolates |
| MIM Households | Dermatophyte Strain Types Among All Enrolled Households | T rubrum strain type | 37 isolates |
| MIM Households | Dermatophyte Strain Types Among All Enrolled Households | T mentagrophytes strain types | 12 isolates |
| MIM Households | Dermatophyte Strain Types Among All Enrolled Households | E Floccosum strain types | 1 isolates |
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.
Time frame: Baseline
Population: This outcome measure was intended to identify the number of households with dermatophyte infection spread in multiple infected member households only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIM Households | Number of Households With Dermatophyte Infection Spread | Spread of Infection due to T Rubrum Isolates | 7 Households |
| SIM Households | Number of Households With Dermatophyte Infection Spread | Spread of Infection due to T Mentagrophytes Isolates | 1 Households |
| SIM Households | Number of Households With Dermatophyte Infection Spread | No Spread of Infection | 10 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.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIM Households | Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis | Spread of Infection and history of tinea pedis or onychomycosis | 0 participants |
| SIM Households | Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis | Spread of Infection and history of both tinea pedis and onychomycosis | 0 participants |
| MIM Households | Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis | Spread of Infection and history of tinea pedis or onychomycosis | 0 participants |
| MIM Households | Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis | Spread of Infection and history of both tinea pedis and onychomycosis | 0 participants |