Clinical Trial: Registry for the Atopic Dermatitis Research Network

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Registry for the Atopic Dermatitis Research Network (ADRN-02)

Brief Summary: The purpose of this multi-center, clinical registry study is to determine genetic markers associated with susceptibility of AD patients to infections and to also serve as a potential participant database for future studies.

Detailed Summary:

People with atopic dermatitis (AD), also known as eczema, experience hot, dry, scaly skin with severe itching. In addition, people with AD are prone to skin infections and inflammation. Little is known about the causes of AD or why people with AD are more prone to infections. The purpose of this multi-center, clinical registry study is to determine genetic markers associated with susceptibility of AD patients to infections and to also serve as a potential participant database for future studies.

Study procedures will usually be completed in one visit to the clinic; however, participants may need to return for one or more additional visits to provide blood and skin swabs if they do not meet sampling criteria at the initial Screening Visit. A subset of participants from National Jewish Health may be asked to return to clinic for 2 additional visits approximately 7 and 14 days after the original sample collection for collection of skin swabs for assessment of antimicrobial activity. All participants may also be asked to return for an Unscheduled Visit to provide additional blood and/or skin swabs. Atopic Dermatitis with previous or current Eczema Herpeticum (ADEH+), Atopic Dermatitis with previous or current Eczema Vaccinatum (ADEV+) and Methicillin-Resistant S. Aureus (MRSA+) participants will be contacted every 6 months for the duration of the study.

Recruitment emphasis will include Non-Hispanic Caucasian, Non-Hispanic African American, and Mexican American since these constitute the three largest racial/ethnic populations according to the U.S. Census Bureau 2009 data; however, no racial/ethnic groups will be excluded. Our scientific rationale for targeting these three racial/ethnic groups is to ensure that we are able to recruit sufficient numbers of participants in each group to perform meaningful tests for genetic assoc
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • Genotype and sequence data from ADEH+ and ADEH- participants. [ Time Frame: Day 1 ]
  • Genotype and sequence data from ADEH- participants with and without bacterial colonization with S. aureus. [ Time Frame: Day 1 ]


Original Primary Outcome:

  • Expand the database of clinical and diagnostic information on participants with AD from the Atopic Dermatitis Vaccinia Network. [ Time Frame: Day 1 ]
  • Genetic variants associated with susceptibility of AD patients to cutaneous viral dissemination. [ Time Frame: Day 1 ]
  • Genetic variants associated with susceptibility of ADEH- patients to bacterial colonization and/or infection with S. aureus. [ Time Frame: Day 1 ]


Current Secondary Outcome:

  • Single Nucleotide Polymorphism (SNP) and Copy Number Variant (CNV) genotype data for candidate genes, including but not limited to Claudin-1 (CLDN1) and Filaggrin (FLG). [ Time Frame: Day 1 ]
  • SNP genotype data for candidate genes, including but not limited to CLDN1 and FLG, validated in samples from an independent AD population. [ Time Frame: Day 1 ]
  • Targeted deep resequencing of candidate genes, including but not limited to CLDN1. [ Time Frame: Day 1 ]
  • Analysis of S. aureus isolates for antibiotic sensitivity [ Time Frame: Day 1 ]
  • Analysis of S. aureus isolates for SCC mec DNA elements. [ Time Frame: Day 1 ]
  • Analysis of S. aureus isolates for expression of virulence or other factors. [ Time Frame: Day 1 ]
  • Expression of biomarkers, including but not limited to serum biomarkers, among AD sub-phenotypes. [ Time Frame: Day 1 ]
  • Analysis of microbial composition by 16S rDNA amplicon sequencing. [ Time Frame: Day 1 ]
  • Analysis of DNA methylation profiles [ Time Frame: Day 1 ]
  • Analysis of mRNA expression profiles in whole blood samples. [ Time Frame: Day 1 ]
  • Frequency of commensal Staphylococcus species producing antimicrobial activity [ Time Frame: Day 1 ]


Original Secondary Outcome:

  • AD patients' S. aureus isolate characterization for factors including but not limited to antibiotic resistance and virulence factors. [ Time Frame: Day 1 ]
  • Creation of a repository of serum samples for assessment of biomarkers associated with atopic dermatitis or susceptibility to cutaneous colonization and/or infections. [ Time Frame: Day 1 ]
  • The diversity of bacterial species in the skin microbiome of AD patients versus non-atopic individuals. [ Time Frame: Day 1 ]
  • S. aureus colonization effect on the susceptibility to colonization and infection with other organisms in ADEH- patients. [ Time Frame: Day 1 ]
  • EH infection effect on the susceptibility to colonization and infection with other organisms in AD patients. [ Time Frame: Day 1 ]


Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: October 31, 2011
Date Started: August 2011
Date Completion: February 2020
Last Updated: October 17, 2016
Last Verified: October 2016