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S. Aureus Colonization in Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02091037
Recruitment Status : Unknown
Verified January 2017 by Christine Lauren, Columbia University.
Recruitment status was:  Active, not recruiting
First Posted : March 19, 2014
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Society for Pediatric Dermatology
Information provided by (Responsible Party):
Christine Lauren, Columbia University

Brief Summary:

The purpose of this study is to characterize the bacterial strains that colonize children with atopic dermatitis.

The investigators hypothesize that rectal cultures will be more sensitive than anterior nares cultures for detecting S. aureus colonization, and that strains of S. aureus colonizing patients with atopic dermatitis will be resistant to commonly used topical antibiotic ointments.


Condition or disease
Atopic Dermatitis

Detailed Description:

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritis and eczematous lesions with a worldwide prevalence of 15-20%. The burden of disease is highest in the most developed nations and predominantly affects children, with 50% of cases arising in the first year of life, and most others arising in the first 5 years. There is a well-known increased susceptibility to skin infection with S. aureus in patients with AD, and such infections are associated with clinical deterioration. While it is routine to evaluate for S. aureus colonization in the anterior nares, there is recent evidence suggesting that rectal colonization may be more significant. The significance of colonization site has not been evaluated in the AD population.

Additionally, while topical antibiotics are a mainstay of treatment in AD, there is no routine data on the resistance to these agents.

Our aim is to characterize the S. aureus colonization patterns in children with AD, including site of colonization and antibiotic resistance. We will analyze routinely-collected skin culture specimens from children with AD seen at our center and determine antibiotic susceptibility profiles. The significance of colonization site will be analyzed.


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Study Type : Observational
Estimated Enrollment : 114 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Staphylococcus Aureus Colonization in Atopic Dermatitis
Study Start Date : December 2011
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema




Primary Outcome Measures :
  1. Difference in rectal and nasal S. aureus colonization rates in a population of children with atopic dermatitis [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Rates of resistance to commonly used topical antibiotic ointments in strains of S. aureus that colonize a population of children with atopic dermatitis [ Time Frame: Up to 20 years ]

Biospecimen Retention:   Samples Without DNA
Skin culture specimens are retained


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from the pediatric dermatology faculty practices and resident clinics at CUMC as well as from the units of the Morgan Stanley Children's Hospital of New York. As per CUMC policy, the investigators will not directly approach potential subjects until the subject's physician has ascertained and documented that their patient is willing to discuss the research with the investigators.
Criteria

Inclusion Criteria:

  • subjects with a diagnosis of atopic dermatitis seen by the Columbia University Medical Center department of dermatology
  • subjects ages 0 to 18 years

Exclusion Criteria:

  • those patients in which a definitive diagnosis of AD cannot be made
  • subjects over the age of 18 years old
  • subjects with evidence of acute systemic illness
  • subjects currently taking systemic antibiotics
  • subjects with viral or fungal skin infection
  • any individual who declines participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091037


Locations
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United States, New York
Columbia University Medical Center / Department of Dermatology
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Society for Pediatric Dermatology

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Responsible Party: Christine Lauren, Assistant Professor of Dermatology and Pediatrics at CUMC, Columbia University
ClinicalTrials.gov Identifier: NCT02091037     History of Changes
Other Study ID Numbers: AAAI5956
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Christine Lauren, Columbia University:
Atopic dermatitis
Bacterial colonization

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases