The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 21, 2005 | ||||
| Last Updated Date | September 16, 2011 | ||||
| Start Date ICMJE | September 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00224926 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation | ||||
| Official Title ICMJE | The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation | ||||
| 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. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: fungal scalp cultures |
||||
| Sampling Method | Probability Sample | ||||
| Study Population | preschool aged children |
||||
| Condition ICMJE | Tinea Capitis | ||||
| Intervention ICMJE | Procedure: Scalp Brushing
sterile, soft-head toothbrush massaged on scalp |
||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 446 | ||||
| Completion Date | September 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 2 Years to 5 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00224926 | ||||
| Other Study ID Numbers ICMJE | PPRU 10704 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Children's Mercy Hospital Kansas City | ||||
| Study Sponsor ICMJE | Children's Mercy Hospital Kansas City | ||||
| Collaborators ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Children's Mercy Hospital Kansas City | ||||
| Verification Date | September 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||