NCT01498744

Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Abscess

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The emergence of community acquired methicillin-resistant Staphylococcus aureus (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 versus 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.

Conditions

• Abscess Soft Tissue
• Methicillin-resistant Staphylococcus Aureus (MRSA) Infection
• Skin Abscess

Interventions

Type	Name	Description
DRUG	Oral Clindamycin	Based on our preliminary susceptibility data, oral clindamycin (10mg/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 \[bactrim\] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-12-23
• Last updated: 2016-02-25
• Results posted: 2016-02-25

Locations

1 site across 1 country: United States