Spread of Dermatophytes Among Families

Completed

• Conditions: Tinea Pedis; Onychomycosis

• Registration Number: NCT00233493
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-05
• Primary Completion: 2009-01
• Study Completion: 2013-05
• Results First Submitted: 2021-07-06
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Results First Posted: 2024-11-01
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

positive dermatophyte culture

Exclusion Criteria

• use of antifungal agents, either oral or topical

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dermatophyte Species Distribution	Baseline	To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States