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Sponsors and Collaborators: |
Children's Memorial Hospital Society for Pediatric Dermatology Johnson & Johnson |
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Information provided by: | Children's Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00179959 |
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 |
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Atopic Dermatitis |
Drug: Sodium hypochlorite baths Drug: Mupirocin ointment Drug: Cephalexin Drug: Water Drug: Petrolatum Ointment |
Phase IV |
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 |
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 |
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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
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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)
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Ages Eligible for Study: | 6 Months to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brook Tlougan, MD | 773-327-9642 | b-tlougan@northwestern.edu |
Contact: Sapna Patel, MD | 773-327-3346 | spatel@childrensmemorial.org |
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 |
Principal Investigator: | Jennifer Huang, MD | Childrens Memorial Hospital |
Study Director: | Amy Paller, MD | Childrens Memorial Hospital |
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 |
Dermatitis, Atopic Mupirocin Skin Diseases Cephalexin Petrolatum Hypersensitivity Genetic Diseases, Inborn |
Sodium Hypochlorite Hypersensitivity, Immediate Skin Diseases, Eczematous Eusol Skin Diseases, Genetic Dermatitis |
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 |