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

NCT ID: NCT01498744

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5 days postoperative antibiotic

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).

Group Type: EXPERIMENTAL

Oral Clindamycin

Intervention Type: DRUG

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).

1 day postoperative antibiotic

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).

Group Type: EXPERIMENTAL

Oral Clindamycin

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Katherine Barsness, MD

Attending Physician, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine A Barsness, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Ann and Robert H Lurie Children's Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB # 2010-14118

Identifier Type: -

Identifier Source: org_study_id