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

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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):

December 20, 2011
December 23, 2011
November 11, 2015
February 25, 2016
February 25, 2016
February 2010
February 2013   (Final data collection date for primary outcome 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 ]
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 ]
Complete list of historical versions of study NCT01498744 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
Not Provided
 
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Abscess Soft Tissue
  • Methicillin-resistant Staphylococcus Aureus (MRSA) Infection
  • Skin Abscess
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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
53
February 2013
February 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Month to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01498744
IRB # 2010-14118
No
Not Provided
Plan to Share IPD: No
Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
Not Provided
Principal Investigator: Katherine A Barsness, MD Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
January 2016

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