S. Aureus Colonization in Atopic Dermatitis

NCT ID: NCT02091037

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-01-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Society for Pediatric Dermatology

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christine T Lauren, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbia University Medical Center / Department of Dermatology

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAAI5956

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Treatments on Atopic Dermatitis
NCT01631617 RECRUITING PHASE2