Atopic Dermatitis Clinical Trial
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 (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.
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 IgE levels between AD
subjects with MRSA, MSSA, or without S. aureus. Approximately 60 ADEH+ and 60 ADEH-
participants will need to be enrolled to find participants with MRSA or MSSA on their skin.
Presence of these bacteria on the skin can only be determined once skin swabs are collected
and tested.
If participants are deemed eligible at screening, they will continue on to the study visit,
which will last for approximately 2-3 hours. At the study visit, participants will be asked
to provide information related to their medical history including infection,
hospitalization, and medication record. Additionally, a skin exam will be performed to
verify diagnosis (ADEH-, ADEH+, or non-atopic); nasal and skin swabs samples will be
collected; tape strippings samples will be collected; and a blood sample will be collected.
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Observational Model: Case Control, Time Perspective: Prospective
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