The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation

NCT ID: NCT00224926

Last Updated: 2011-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 446 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2005-09-30

Brief Summary

To explore carrier and infection status of T.tonsurans tinea capitis and characterize the host-pathogen interaction as it relates to the disease presentation. The general hypothesis for this study is as follows: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.The global outcome of this investigation is to reveal potential new drug targets designed to improve treatment outcomes in these children.

Detailed Description

Tinea capitis is an overwhelmingly prevalent disease of childhood estimated to be present in approximately 1 in 20 children at any point in time with an equal number of children serving as carriers of the fungal pathogen. Despite the widespread nature of the disease, the natural course of the infection remains incompletely described. The study will be driven by the following hypothesis: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.

A fungal scalp culture will be acquired from all participants using a brush culture technique. Samples will be collected once a month over a two year time period.

Conditions

Tinea Capitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Scalp Brushing

sterile, soft-head toothbrush massaged on scalp

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Preschool aged children will be eligible.

Exclusion Criteria

• None

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Rahman, PharmD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hosptials and Clinics

Locations

Children's Mercy Hospital

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

PPRU 10704

Identifier Type: -

Identifier Source: org_study_id