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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01498744
Recruitment Status : Terminated (The study was closed due to poor enrollment and lack of interest.)
First Posted : December 23, 2011
Results First Posted : February 25, 2016
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Tracking Information
First Submitted Date  ICMJE December 20, 2011
First Posted Date  ICMJE December 23, 2011
Results First Submitted Date  ICMJE November 11, 2015
Results First Posted Date  ICMJE February 25, 2016
Last Update Posted Date February 25, 2016
Study Start Date  ICMJE February 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
The primary objective is to measure 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Additional Skin and Soft Tissue Infections in Patient [ Time Frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op ]
    The outcome measure was reported by responding to a yes/no
  • 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 ]
  • Complication to Antibiotic Regime [ Time Frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
Secondary outcomes measured include incidence of additional skin and soft tissue infections in patient and in household contacts as determined by healthcare provider. Compliance to antibiotic regime will also be assessed at this time. [ Time Frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Abscess
Official Title  ICMJE Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Abscess Soft Tissue
  • Methicillin-resistant Staphylococcus Aureus (MRSA) Infection
  • Skin Abscess
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Oral Clindamycin
  • 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).
    Intervention: Drug: Oral Clindamycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 27, 2016)
53
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2011)
250
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01498744
Other Study ID Numbers  ICMJE IRB # 2010-14118
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Study Sponsor  ICMJE Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katherine A Barsness, MD Ann & Robert H Lurie Children's Hospital of Chicago
PRS Account Ann & Robert H Lurie Children's Hospital of Chicago
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP