Clinical Trial: The Underlying Mechanisms For S. Aureus Infection And Colonization Of Skin in People With Atopic Dermatitis With And Without Eczema Herpeticum (MRSA)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official 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 (AD

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.


Detailed Summary:

The emergence of drug-resistant staphylococcal strains was first seen in the US almost a decade ago, when the Centers for Disease Control (CDC) reported four fatal community-based MRSA infections in children. In recent years, MRSA has grown into a serious public health concern with an increasing number of both hospital-acquired and community-acquired cases being seen.

There will be approximately 130 participants recruited for this trial. The study population will consist of people with Atopic Dermatitis (AD) and people without Atopic Dermatitis (non-atopic). AD is a skin disorder with an itchy, red skin rash. People with AD are more likely to get bacterial and viral skin infections, possibly because they lack certain proteins in their skin, which help the body's immune system to fight infections. AD people with a history of Eczema Herpeticum (EH) may also be at greater risk for being infected with MRSA. This could be due to extended treatment courses with staphylococcal antibiotics, especially because overuse and misuse of antibiotics can lead to bacterial antibiotic resistance. The precise reasons are unknown. The purpose of this study is to determine the reasons for infection in AD participants with and without a history of EH.

Investigators are seeking to recruit patients with either Methicillin-sensitive staphylococcus aureus (MSSA) or MRSA bacteria on their skin, so that they may adequately study potential factors related to MRSA infection.

Investigators will determine if the MRSA collected from people with AD is primarily community or hospital associated. They will also determine if the proteins on the skin of ADEH+ people with MRSA differ from the proteins on the skin of AD people with MSSA or people without AD, or if there are any marked differences in serum total I
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: MRSA isolates from nasal and/or skin swabs will be characterized as either nosocomial or community-associated [ Time Frame: At Study Entry ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. [ Time Frame: At Study Entry ]
  • Genomic analyses of superficial bacterial flora from lesional and non-lesional skin swab samples [ Time Frame: At Study Entry ]


Original Secondary Outcome:

  • Metabolomic/proteomic profiling conducted on taped stripped skin samples to identify potential biomarkers associated with susceptibility to MRSA colonization [ Time Frame: At Study Entry ]
  • Genomic analyses of superficial bacterial flora from lesional and non-lesional skin swab samples [ Time Frame: At Study Entry ]


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

Dates:
Date Received: January 12, 2009
Date Started: February 2009
Date Completion:
Last Updated: April 3, 2014
Last Verified: April 2014