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

Study results available
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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00179959 on ClinicalTrials.gov