Atopic DermatitisNCT02091037
S. Aureus Colonization in Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 11 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- subjects with a diagnosis of atopic dermatitis seen by the Columbia University Medical Center department of dermatology
- subjects ages 0 to 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center / Department of Dermatology
New York, New York, 10032
About this study
Official title: Staphylococcus 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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Bacterial colonization
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in rectal and nasal S. aureus colonization rates in a population of children with atopic dermatitis
Measured: 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
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2016
- Study completion11 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Pediatric Dermatology
- Responsible party
- Sponsor
- Investigators
- Christine T Lauren, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091037
- Sponsor's protocol ID
- AAAI5956
- Status last verified
- Jan 2022
- First submitted
- 17 Mar 2014
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylococcus Aureus Colonization in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02091037
- Acronym / sponsor ID
- AAAI5956
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Bacterial colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Society for Pediatric Dermatology
- Study start
- Dec 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- 11 Jan 2017 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- subjects with a diagnosis of atopic dermatitis seen by the Columbia University Medical Center department of dermatology
- subjects ages 0 to 18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in rectal and nasal S. aureus colonization rates in a population of children with atopic dermatitis
Time frame: Up to 3 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine T Lauren, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in rectal and nasal S. aureus colonization rates in a population of children with atopic dermatitis (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.