Trial Outcomes & Findings for Spread of Dermatophytes Among Families (NCT NCT00233493)

Results Overview

To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR)

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

Baseline

Results posted on

2024-11-01

Participant Flow

Unit of analysis: Households

Participant milestones

Participant milestones
Measure	One Infected Member One infected member in multiple person household	2 or More Infected Members Two or more infected members in a multiple person household
Overall Study STARTED	32 32	18 18
Overall Study COMPLETED	32 32	18 18
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Spread of Dermatophytes Among Families

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Person Households n=32 Participants Households with at least 1 resident with tinea pedis and/or onychommycosis.	Multiperson Households n=18 Participants Households with at least 2 residents and 1 individual with tinea pedis and /or onychommycosis.	Total n=50 Participants Total of all reporting groups
Age, Continuous	57.73 Years STANDARD_DEVIATION 17.61 • n=5 Participants	50.33 Years STANDARD_DEVIATION 20.80 • n=7 Participants	54.03 Years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	6 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	18 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR)

Outcome measures

Outcome measures
Measure	SIM Households n=32 Households SIM Households in which dermatophyte isolates were isolated	MIM Households n=18 Households MIM Households in which dermatophyte isolates were identified
Dermatophyte Species Distribution T Rubrum Isolates	50 isolates	37 isolates
Dermatophyte Species Distribution T Mentagrophytes Isolates	5 isolates	12 isolates
Dermatophyte Species Distribution E Floccosum Isolates	2 isolates	1 isolates

SECONDARY outcome

Timeframe: Baseline

Using southern blot analysis and RFLP to evaluate the isolates and strain types obtained from all enrolled households

Outcome measures

Outcome measures
Measure	SIM Households n=32 Households SIM Households in which dermatophyte isolates were isolated	MIM Households n=18 Households MIM Households in which dermatophyte isolates were identified
Dermatophyte Strain Types Among All Enrolled Households T rubrum strain type	50 isolates	37 isolates
Dermatophyte Strain Types Among All Enrolled Households T mentagrophytes strain types	5 isolates	12 isolates
Dermatophyte Strain Types Among All Enrolled Households E Floccosum strain types	2 isolates	1 isolates

SECONDARY outcome

Timeframe: Baseline

Population: This outcome measure was intended to identify the number of households with dermatophyte infection spread in multiple infected member households only.

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.

Outcome measures

Outcome measures
Measure	SIM Households n=18 Households SIM Households in which dermatophyte isolates were isolated	MIM Households MIM Households in which dermatophyte isolates were identified
Number of Households With Dermatophyte Infection Spread Spread of Infection due to T Rubrum Isolates	7 Households	—
Number of Households With Dermatophyte Infection Spread Spread of Infection due to T Mentagrophytes Isolates	1 Households	—
Number of Households With Dermatophyte Infection Spread No Spread of Infection	10 Households	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SIM Households n=32 Households SIM Households in which dermatophyte isolates were isolated	MIM Households n=18 Households MIM Households in which dermatophyte isolates were identified
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	0 participants
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	0 participants

Adverse Events

Multi Person Households

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single Person Household

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mahmoud Ghannoum

University Hospitals Cleveland Medical Center Center for Medical Mycology

Phone: 216-844-8580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place