The Underlying Mechanisms For S. Aureus Infection And Colonization Of Skin in People With Atopic Dermatitis With And Without Eczema Herpeticum (MRSA)
MRSA
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)
1 other identifier
observational
65
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2009
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2009
CompletedFirst Posted
Study publicly available on registry
January 14, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedApril 4, 2014
April 1, 2014
9 months
January 12, 2009
April 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MRSA isolates from nasal and/or skin swabs will be characterized as either nosocomial or community-associated
At Study Entry
Secondary Outcomes (2)
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
Genomic analyses of superficial bacterial flora from lesional and non-lesional skin swab samples
At Study Entry
Study Arms (7)
ADEH+ participants colonized with MSSA
ADEH+ participants colonized with MRSA
Uncolonized ADEH+ participants
ADEH- participants colonized with MSSA
ADEH- participants colonized with MRSA
Uncolonized ADEH- subjects
Non-atopic uncolonized S. aureus participants
Eligibility Criteria
ADEH-, ADEH+ people who may or may not be colonized with MRSA or MSSA, and non-atopic people not colonized with MRSA or MSSA.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California, San Diego
San Diego, California, 92161, United States
National Jewish Health
Denver, Colorado, 80206, United States
Related Publications (1)
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.
PMID: 18419342RESULT
Related Links
Biospecimen
Nasal swabs, skin swabs, tape strippings, and blood draws.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Leung, MD, PhD
National Jewish Health
- PRINCIPAL INVESTIGATOR
Richard Gallo, MD, PhD
University of California, San Diego
- PRINCIPAL INVESTIGATOR
Gloria David, PhD, MHSc
Rho, Inc.
- PRINCIPAL INVESTIGATOR
Patrick Schlievert, PhD
University of Minnesota
- PRINCIPAL INVESTIGATOR
Nichole Reisdorph, PhD, MS
National Jewish Health
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2009
First Posted
January 14, 2009
Study Start
February 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
April 4, 2014
Record last verified: 2014-04