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

Skin Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01498744
• Other study ID #: IRB # 2010-14118
• Status: Terminated
• Phase: N/A
• First received: December 20, 2011
• Last updated: January 27, 2016
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: January 2016
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 17 Years

Eligibility

Inclusion Criteria:

• Children between 1 month and 17 years of age who undergo Incision and Drainage of a skin and soft tissue abscess by a member of the Children's Memorial Hospital pediatric surgery faculty.

Exclusion Criteria:

• Children who developed their infection while hospitalized or within 2 weeks of unrelated hospital discharge will be excluded.

• Children with surgical site infections will be excluded.

• Children with inherent or acquired immunodeficiency, including but not limited to transplant patients and patients on chemotherapy or systemic corticosteroids will be excluded.

• Patients admitted to the Infectious Disease service may be excluded at the discretion of the ID attending.

• Patients who are found to have no discreet fluid collections at the time of attempted incision and drainage will be excluded.

• Patients allergic or intolerant to both bactrim and clindamycin will be excluded.

• Patients with cellulitis greater than 5 cm beyond the lateral margin of the abscess (as determined by intraoperative measurements) will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
United States	Ann and Robert H Lurie Children's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.		At office visit 10-14 days post operation	No
Secondary	Additional Skin and Soft Tissue Infections in Patient	The outcome measure was reported by responding to a yes/no	Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op	No
Secondary	Additional Skin or Soft Tissue Infections in Household Contacts		Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op	No
Secondary	Complication to Antibiotic Regime		Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op	No