Spread of Dermatophytes Among Families

August 15, 2024 updated by: University Hospitals Cleveland Medical Center

Demonstration of the Spread of Dermatophytes Through Casual Contact Among Family Household Members

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria: positive dermatophyte culture

Exclusion Criteria:

use of antifungal agents, either oral or topical

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Defined Population
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatophyte Species Distribution Time Frame: Baseline	To identify dermatophytes isolates known to cause onychomycosis and/or tinea pedis by Polymerase Chain Reaction (PCR)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatophyte Strain Types Among All Enrolled Households Time Frame: Baseline	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 Time Frame: 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.	Baseline
Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis Time Frame: 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.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Novartis Pharmaceuticals

Investigators

Principal Investigator: Mahmoud A Ghannoum, PhD, Center for Medical Mycology, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria