Clinical Trial Review

March 2013 | Volume 12 | Issue 3 | Feature | 379 | Copyright © 2013

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Abstract

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

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SKIN AND SOFT TISSUE ABSCESS

Randomized Controlled Trial of Antibiotics in the Management of Children With Community- Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage

Sponsored by Ann & Robert H Lurie Children’s Hospital of Chicago, the purpose of this study is to better understand why children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether antibiotics are helpful after the infection is drained in the operating room.

The emergence of community-acquired MRSA as a pervasive cause of skin and soft tissue infections has increased the number of children requiring incision and drainage (I&D) procedures and heightened concerns about the optimal treatment strategy. Data on patients with methicillin-sensitive Staphylococcus aureus (MSSA) abscesses, as well as emerging data on children with minor MRSA skin and soft tissue abscesses suggest that I&D alone is sufficient therapy. However, given concerns about the pathogenicity of MRSA infections, many patients who require hospital admission and I&D in the operating room receive postoperative antibiotics. The primary objective of this randomized controlled trial is to compare the effect of 5 days vs 1 day of postoperative antibiotics on the rate of treatment failure following I&D of abscesses in children in the era of pervasive MRSA infection. Secondary outcomes to be measured include incidence of additional skin and soft tissue infections in other body sites and incidence of these infections in family members and household contacts. Prospective data will be collected from wound cultures, as well as from nasal, rectal, and skin cultures sent at the time of initial I&D to assess for MRSA carrier status. Finally, survey data will be used to assess epidemiologic risk factors.

Based on our preliminary susceptibility data, oral clindamycin (10 mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5 mg/kg trimethoprim up to 160 mg, every 12 hours). The primary objective is to measure clinical resolution of skin abscess at routine followup visit 10 to 14 days postoperation. Secondary outcomes measured include incidence of additional skin and soft tissue infections in patients and in household contacts, as determined by health care provider. Compliance to antibiotic regime will also be assessed at this time (10-14 days postoperation, 3 months postoperation, and 9 months postoperation.

Children aged between 1 month and 17 years who undergo I&D of a skin and soft tissue abscess by a member of the Children’s Memorial Hospital pediatric surgery faculty are eligible for inclusion in this study. The following patients will be excluded from participation: children who developed their infection while hospitalized or within 2 weeks of unrelated hospital discharge; children with surgical-site infections; children with inherent or acquired immunodeficiency, including but not limited to transplant patients and patients on chemotherapy or systemic corticosteroids; patients admitted to the Infectious Disease (ID) service may be excluded at the discretion of the ID attending; patients who are found to have no discrete fluid collections at the time of attempted I&D; patients allergic or intolerant to both bactrim and clindamycin; and patients with cellulitis greater than 5 cm beyond the lateral margin of the abscess (as determined by intraoperative measurements).

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ATOPIC DERMATITIS

A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis

Sponsored by the National Institute of Allergy and Infectious Diseases, the purpose of this study is to assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis in children. Severe refractory atopic dermatitis is a chronic inflammatory pruritic skin condition that affects both children and adults. The disease is marked by periods of exacerbation and remission. Symptoms of atopic dermatitis may resolve by adolescence; however, it is estimated that the disease may persist in 50% of affected children well into adulthood.

Current possible treatments of atopic dermatitis include the use of topical corticosteroids, calcineurin inhibitors, phototherapy, as well as systemic medications, eg, methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, and interferon-γ. The difficulty with long-term treatment of this disease lies in its chronic nature associated with severe episodes. The combination of chronicity and severity of episodes of this diseases demands more effective and better-tolerated therapeutic options than those that are currently available. While the pathways of allergic inflammation are different than those of other inflam-

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