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The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis
This study is currently recruiting participants.
Verified by Children's Memorial Hospital, June 2008
Sponsors and Collaborators: Children's Memorial Hospital
Society for Pediatric Dermatology
Johnson & Johnson
Information provided by: Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179959
  Purpose

Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. We would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.


Condition Intervention Phase
Atopic Dermatitis
Drug: Sodium hypochlorite baths
Drug: Mupirocin ointment
Drug: Cephalexin
Drug: Water
Drug: Petrolatum Ointment
Phase IV

MedlinePlus related topics: Dietary Sodium Drinking Water
Drug Information available for: Cephalexin Cephalexin hydrochloride Mupirocin Mupirocin calcium Petrolatum Sodium hypochlorite
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis

Further study details as provided by Children's Memorial Hospital:

Primary Outcome Measures:
  • Clinical Severity of atopic dermatitis based upon Investigator's Global Assessment and EASI score [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety outcomes, Pruritis scale [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: September 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: Sodium hypochlorite baths
Sodium hypochlorite baths twice weekly x three months
Drug: Mupirocin ointment
Intranasal mupirocin 2% ointment BID x five days (3 times total for subjects; one time only for family members)
Drug: Cephalexin
Cephalexin 50mg/kg/day (maximum of 2grams/day) divided TID x two weeks
2: Placebo Comparator Drug: Cephalexin
Cephalexin 50mg/kg/day (maximum of 2grams/day) divided TID x two weeks
Drug: Water
Water baths twice weekly x three months
Drug: Petrolatum Ointment
Intranasal petrolatum ointment BID x five days (subjects will do this 3 times, families once)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months to 17 years of age
  • Moderate to severe atopic dermatitis

Exclusion Criteria:

  • Use of cephalexin or other antibiotic in last 6 weeks
  • Allergy to cephalosporins
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179959

Contacts
Contact: Brook Tlougan, MD 773-327-9642 b-tlougan@northwestern.edu
Contact: Sapna Patel, MD 773-327-3346 spatel@childrensmemorial.org

Locations
United States, Illinois
Childrens Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Contact: Brook Tlougan, MD     773-327-9642     b-tlougan@northwestern.edu    
Contact: Jen Huang, MD         jenhuang711@gmail.com    
Sponsors and Collaborators
Children's Memorial Hospital
Society for Pediatric Dermatology
Johnson & Johnson
Investigators
Principal Investigator: Jennifer Huang, MD Childrens Memorial Hospital
Study Director: Amy Paller, MD Childrens Memorial Hospital
  More Information

Responsible Party: Children's Memorial Hospital ( Amy Paller, M.D. )
Study ID Numbers: 12624
Study First Received: September 13, 2005
Last Updated: June 5, 2008
ClinicalTrials.gov Identifier: NCT00179959  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Dermatitis, Atopic
Mupirocin
Skin Diseases
Cephalexin
Petrolatum
Hypersensitivity
Genetic Diseases, Inborn
Sodium Hypochlorite
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Eusol
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Disinfectants
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Enzyme Inhibitors
Dermatologic Agents
Pharmacologic Actions
Emollients

ClinicalTrials.gov processed this record on January 14, 2009