Phase 4
N=31
The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT00179959 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Change in Eczema Area and Severity Index (EASI)Scores According to Location — -1.06; -0.57; -4.94; -0.88 Change in EASI Score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sodium hypochlorite (bleach) baths (Drug); Mupirocin ointment (Drug); Water (Drug); Petrolatum Ointment (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Eczema Area and Severity Index (EASI)Scores According to Location |
-1.06; -0.57; -4.94; -0.88 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00179959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.