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

April 3, 2014 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • University of California, San Diego
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ADEH-, ADEH+ people who may or may not be colonized with MRSA or MSSA, and non-atopic people not colonized with MRSA or MSSA.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
MRSA isolates from nasal and/or skin swabs will be characterized as either nosocomial or community-associated
Time Frame: At Study Entry
At Study Entry

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
At Study Entry
Genomic analyses of superficial bacterial flora from lesional and non-lesional skin swab samples
Time Frame: At Study Entry
At Study Entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAIT ADVN MRSA 10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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