Methicillin-Resistant Staphylococcus AureusMRSANCT00822276
The Underlying Mechanisms For S. Aureus Infection And Colonization Of Skin in People With Atopic Dermatitis With And Without Eczema Herpeticum (MRSA)
An observational study of Methicillin-Resistant Staphylococcus Aureus and Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus, Atopic Dermatitis, Eczema Herpeticum
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Jewish Health
Denver, Colorado, 80206
University of California, San Diego
San Diego, California, 92161
About this study
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.
Read the 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.
- Keywords
- Methicillin-resistant Staphylococcus aureus, MRSA, Methicillin-sensitive Staphylococcus aureus, MSSA, Atopic Dermatitis, Eczema Herpeticum
- Medical subject headings
- Dermatitis, Atopic, Kaposi Varicelliform Eruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ADEH+ participants colonized with MSSA | Not described | |
| ADEH+ participants colonized with MRSA | Not described | |
| Uncolonized ADEH+ participants | Not described | |
| ADEH- participants colonized with MSSA | Not described | |
| ADEH- participants colonized with MRSA | Not described | |
| Uncolonized ADEH- subjects | Not described | |
| Non-atopic uncolonized S. aureus participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRSA isolates from nasal and/or skin swabs will be characterized as either nosocomial or community-associated
Measured: 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.
Measured: At Study Entry
Genomic analyses of superficial bacterial flora from lesional and non-lesional skin swab samples
Measured: At Study Entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methicillin-Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Donald Leung, MD, PhD, Principal investigator, National Jewish HealthRichard Gallo, MD, PhD, Principal investigator, University of California, San DiegoGloria David, PhD, MHSc, Principal investigator, Rho, Inc.Patrick Schlievert, PhD, Principal investigator, University of MinnesotaNichole Reisdorph, PhD, MS, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822276
- Sponsor's protocol ID
- DAIT ADVN MRSA 10
- Acronym
- MRSA
- Status last verified
- Apr 2014
- First submitted
- 12 Jan 2009
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18419342
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00822276
- Acronym / sponsor ID
- MRSA / DAIT ADVN MRSA 10
- Keywords
- Methicillin-resistant Staphylococcus aureus, MRSA, Methicillin-sensitive Staphylococcus aureus, MSSA, Atopic Dermatitis, Eczema Herpeticum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRSA isolates from nasal and/or skin swabs will be characterized as either nosocomial or community-associated
Time frame: At Study Entry
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
- Results publication: PubMed 18419342Schlievert 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.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Leung, MD, PhD principal investigator
National Jewish Health
Richard Gallo, MD, PhD principal investigator
University of California, San Diego
Gloria David, PhD, MHSc principal investigator
Rho, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methicillin-Resistant Staphylococcus Aureus and Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRSA isolates from nasal and/or skin swabs will be characterized as either nosocomial or community-associated (time frame: At Study Entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.