Spread of Dermatophytes Among Families

NCT00233493 | Completed Results

• 1 other identifier: CSFO327KUS16
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis; Tinea Pedis

Keywords

dermatophytes

Outcome Measures

Primary Outcomes (1)

• Dermatophyte Species Distribution

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

  Baseline

Secondary Outcomes (3)

• Dermatophyte Strain Types Among All Enrolled Households

  Baseline

• Number of Households With Dermatophyte Infection Spread

  Baseline

• Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis

  Baseline

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• use of antifungal agents, either oral or topical

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Onychomycosis; Tinea Pedis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

A cross-sectional, not longitudinal, analysis; therefore, we were unable to determine the chronology of infection, the cause-and-effect relationship between specific strain types and infection, or the household member that was infected first.

Results Point of Contact

• Title: Dr. Mahmoud Ghannoum
• Organization: University Hospitals Cleveland Medical Center Center for Medical Mycology

Mahmoud.Ghannoum@case.edu

216-844-8580

Study Officials

• Mahmoud A Ghannoum, PhD

  Center for Medical Mycology, University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: March 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: May 1, 2013
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-08

Locations

US (1)