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NCT02091037 Clinical Trial

S. Aureus Colonization in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
Staphylococcus Aureus Colonization in Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02091037
Other study ID # AAAI5956
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2011
Est. completion date January 11, 2017

Study information
Verified date January 2022
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date January 11, 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Columbia University Medical Center / Department of Dermatology New York New York

Sponsors (2)
Lead Sponsor Collaborator
Columbia University Society for Pediatric Dermatology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in rectal and nasal S. aureus colonization rates in a population of children with atopic dermatitis Up to 3 years
Secondary Rates of resistance to commonly used topical antibiotic ointments in strains of S. aureus that colonize a population of children with atopic dermatitis Up to 20 years
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