Atopic Dermatitis Clinical Trial
— MRSAOfficial title:
Pilot Study To Determine The Underlying Mechanisms For Infection And Colonization By Staphylococcus Aureus Of The Skin Of Atopic Dermatitis Subjects With And Without A History Of Eczema Herpeticum (ADVN MRSA 10)
Staphylococcus aureus (S.aureus) is a bacterium that causes many painful skin and soft
tissue conditions, such as scalded-skin syndrome, boils, or impetigo. Serious cases may
result in deadly complications but S.aureus can usually be treated successfully with
antibiotics. There are, however, certain strains which cannot be treated with standard
antibiotics. Methicillin-resistant staphylococcus aureus (MRSA) is one such strain.
MRSA is increasingly being seen in both hospital and community settings, making it a serious
public health issue. People with Atopic Dermatitis (AD), particularly those with a history
of Eczema Herpeticum (EH), may be at greater risk for infection by MRSA. The reason for this
higher risk is unknown but may be linked to extended treatment with staphylococcus
antibiotics in addition to the absence of certain proteins on their skin, which have immune
function. The purpose of this study is to determine the reasons for MRSA infection in AD
participants with and without a history of EH.
Status | Completed |
Enrollment | 65 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 1 Year to 80 Years |
Eligibility |
Inclusion Criteria: - Parent, or legal guardian willing to provide informed consent, if necessary - Residing in the U.S. - Have active AD with or without a history of EH as diagnosed using the ADVN Standardized Diagnostic Criteria OR are non-atopic as diagnosed using the ADVN Standardized Diagnostic Criteria Exclusion Criteria: - History of any systemic illness (i.e., immunodeficiency disorders such as human immunodeficiency virus [HIV] or lupus erythematosus) other than the condition being studied - Presence of active systemic malignancy, excluding uncomplicated non-melanoma skin cancer - Presence of any skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous disease, psoriasis, cutaneous T cell lymphoma [also called Mycosis Fungoides or Sezary syndrome]) - Use of topical medications including (but not limited to) Elidel, Protopic, or topical corticosteroids at the site of the skin lesion within the last 3 days - Use of topical antibiotics within the last 24 hours - Use of oral antibiotics within the last 10 days. Subjects who are known to be culture positive for MSSA or MRSA despite antibiotic treatment will not be excluded. - History of serious or life-threatening reactions to tape or adhesives will be excluded from the tape stripping procedure |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | National Jewish Health | Denver | Colorado |
United States | University of California, San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Schlievert PM, Case LC, Strandberg KL, Abrams BB, Leung DY. Superantigen profile of Staphylococcus aureus isolates from patients with steroid-resistant atopic dermatitis. Clin Infect Dis. 2008 May 15;46(10):1562-7. doi: 10.1086/586746. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRSA isolates from nasal and/or skin swabs will be characterized as either nosocomial or community-associated | At Study Entry | No | |
Secondary | Proteomic profiling will be conducted on taped stripped skin samples of lesional and non-lesional skin in order to identify potential biomarkers associated with susceptibility to MRSA colonization. Metabolomic profiling may be conducted pending funding. | At Study Entry | No | |
Secondary | Genomic analyses of superficial bacterial flora from lesional and non-lesional skin swab samples | At Study Entry | No |
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