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Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829686
First Posted: January 27, 2009
Last Update Posted: June 9, 2017
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):
Gillian Schmitz, Wilford Hall Medical Center
January 26, 2009
January 27, 2009
June 5, 2009
July 28, 2009
June 9, 2017
June 2008
June 2008   (Final data collection date for primary outcome measure)
Clinical Improvement at 7 Days After Incision and Drainage [ Time Frame: 7 days ]
improving wound without evidence of fever, worsening cellulitis or induration
Clinical Improvement at 7 Days After Incision and Drainage [ Time Frame: 7 days ]
Complete list of historical versions of study NCT00829686 on ClinicalTrials.gov Archive Site
Recurrence Rates [ Time Frame: 30 days ]
recurrence of abscess in previous or new location within 30 days
Recurrence Rates [ Time Frame: 30 days ]
Not Provided
Not Provided
 
Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection
Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Abscess
Drug: Septra
(800/125) PO BID X 7 days
  • No Intervention: No intervention
    No antibiotic
  • Active Comparator: Septra DS
    Septra DS (800/160) two pills PO BID x 7 days
    Intervention: Drug: Septra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
June 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients age 18-55 who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

  • patients with diabetes, HIV, cancer or other immunocompromised patients
  • patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables
  • pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment
  • basic Military Trainees will also be excluded from participation
  • patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded
  • patients with sulfa allergy will be excluded.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00829686
FWH20080055H-Pilot
No
Not Provided
Not Provided
Gillian Schmitz, Wilford Hall Medical Center
Wilford Hall Medical Center
Not Provided
Not Provided
Wilford Hall Medical Center
May 2017

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