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

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.

Study Overview

• Status: Terminated
• Conditions: Skin Abscess; Abscess Soft Tissue; Methicillin-resistant Staphylococcus Aureus (MRSA) Infection
• Intervention / Treatment: Drug: Oral Clindamycin

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann and Robert H Lurie Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	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).
EXPERIMENTAL: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.	At office visit 10-14 days post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Complication to Antibiotic Regime		Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (ESTIMATE): December 23, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 25, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Incision and Drainage; Clindamycin; Skin Infection; Trimethoprim-sulfamethoxazole; Methicillin-resistant Staphylococcus aureus (MRSA); Skin and Soft Tissue Abscess
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Suppuration; Abscess; Staphylococcal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate
• Other Study ID Numbers: IRB # 2010-14118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO