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

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Clindamycin
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess Soft Tissue focused on measuring Skin and Soft Tissue Abscess, Methicillin-resistant Staphylococcus aureus (MRSA), Incision and Drainage, Clindamycin, Trimethoprim-sulfamethoxazole, Skin Infection

Eligibility Criteria

1 Month - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ann and Robert H Lurie Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

5 days postoperative antibiotic

1 day postoperative antibiotic

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.

Secondary Outcome Measures

Additional Skin and Soft Tissue Infections in Patient
The outcome measure was reported by responding to a yes/no
Additional Skin or Soft Tissue Infections in Household Contacts
Complication to Antibiotic Regime

Full Information

First Posted
December 20, 2011
Last Updated
January 27, 2016
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01498744
Brief Title
Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Abscess
Official Title
Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
The study was closed due to poor enrollment and lack of interest.
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess Soft Tissue, Methicillin-resistant Staphylococcus Aureus (MRSA) Infection, Skin Abscess
Keywords
Skin and Soft Tissue Abscess, Methicillin-resistant Staphylococcus aureus (MRSA), Incision and Drainage, Clindamycin, Trimethoprim-sulfamethoxazole, Skin Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 days postoperative antibiotic
Arm Type
Experimental
Arm Description
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).
Arm Title
1 day postoperative antibiotic
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Oral Clindamycin
Intervention Description
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).
Primary Outcome Measure Information:
Title
Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.
Time Frame
At office visit 10-14 days post operation
Secondary Outcome Measure Information:
Title
Additional Skin and Soft Tissue Infections in Patient
Description
The outcome measure was reported by responding to a yes/no
Time Frame
Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Title
Additional Skin or Soft Tissue Infections in Household Contacts
Time Frame
Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Title
Complication to Antibiotic Regime
Time Frame
Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine A Barsness, MD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann and Robert H Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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