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

This study has been terminated.
(The study was closed due to poor enrollment and lack of interest.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498744
First Posted: December 23, 2011
Last Update Posted: February 25, 2016
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.
Information provided by (Responsible Party):
Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago
  Purpose
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.

Condition Intervention
Abscess Soft Tissue Methicillin-resistant Staphylococcus Aureus (MRSA) Infection Skin Abscess Drug: Oral Clindamycin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage

Resource links provided by NLM:


Further study details as provided by Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 53
Study Start Date: February 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498744


Locations
United States, Illinois
Ann and Robert H Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Katherine A Barsness, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Responsible Party: Katherine Barsness, MD, Attending Physician, Department of Surgery, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01498744     History of Changes
Other Study ID Numbers: IRB # 2010-14118
First Submitted: December 20, 2011
First Posted: December 23, 2011
Results First Submitted: November 11, 2015
Results First Posted: February 25, 2016
Last Update Posted: February 25, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
Skin and Soft Tissue Abscess
Methicillin-resistant Staphylococcus aureus (MRSA)
Incision and Drainage
Clindamycin
Trimethoprim-sulfamethoxazole
Skin Infection

Additional relevant MeSH terms:
Abscess
Staphylococcal Infections
Suppuration
Infection
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Trimethoprim, Sulfamethoxazole Drug Combination
Antibiotics, Antitubercular
Trimethoprim
Sulfamethoxazole
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors