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Completed

NCT Number: NCT00233493

Spread of Dermatophytes Among Families

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.

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Foot Dermatoses Foot Diseases Infections Mycoses Nail Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea Tinea Pedis

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

positive dermatophyte culture

-

Exclusion criteria

  • use of antifungal agents, either oral or topical

Treatment and study plan

Primary outcomes

  1. Dermatophyte Species Distribution

    Time frame: Baseline

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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2013
First posted
Oct 5, 2005
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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