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OpenTrials
Completed

NCT Number: NCT02091037

S. Aureus Colonization in Atopic Dermatitis

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center / Department of Dermatology

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Society for Pediatric Dermatology

Registry information

Official study title

Staphylococcus Aureus Colonization in Atopic Dermatitis

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Mar 19, 2014
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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