The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis
NCT00179959 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2014-12-08
Summary
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. The investigators 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.
Conditions
Interventions
- DRUG
-
Sodium hypochlorite (bleach) baths
Sodium hypochlorite (bleach) baths twice weekly for 3 months
- DRUG
-
Mupirocin ointment
Intranasal mupirocin 2% ointment BID x five days (3 times total for subjects; one time only for family members)
- DRUG
-
Water
Water baths twice weekly for three months
- DRUG
-
Petrolatum Ointment
Intranasal petrolatum ointment twice daily for five days
Sponsors & Collaborators
-
Society for Pediatric Dermatology
collaborator OTHER - collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Amy Paller, MD · Childrens Memorial Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-09-30
- Primary Completion
- 2011-03-31
- Completion
- 2011-03-31
Countries
- United States
Study Locations
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