NCT02091037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2017

Completed
Last Updated

January 10, 2022

Status Verified

January 1, 2022

Enrollment Period

5 years

First QC Date

March 17, 2014

Last Update Submit

January 5, 2022

Conditions

Keywords

Atopic dermatitisBacterial colonization

Outcome Measures

Primary Outcomes (1)

  • Difference in rectal and nasal S. aureus colonization rates in a population of children with atopic dermatitis

    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

    Up to 20 years

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center / Department of Dermatology

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin culture specimens are retained

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Christine T Lauren, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 19, 2014

Study Start

December 1, 2011

Primary Completion

December 1, 2016

Study Completion

January 11, 2017

Last Updated

January 10, 2022

Record last verified: 2022-01

Locations