- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02091037
S. Aureus Colonization in Atopic Dermatitis
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center / Department of Dermatology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Difference in rectal and nasal S. aureus colonization rates in a population of children with atopic dermatitis
Tidsramme: Up to 3 years
|
Up to 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rates of resistance to commonly used topical antibiotic ointments in strains of S. aureus that colonize a population of children with atopic dermatitis
Tidsramme: Up to 20 years
|
Up to 20 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christine T Lauren, MD, Columbia University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AAAI5956
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