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Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection

This study has been completed.
Sponsor:
Collaborators:
U.S. Air Force Office of the Surgeon General
Emergency Medicine Foundation
Information provided by (Responsible Party):
Gillian Schmitz, Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT00822692
First received: January 13, 2009
Last updated: December 17, 2015
Last verified: December 2015

January 13, 2009
December 17, 2015
July 2008
June 2009   (final data collection date for primary outcome measure)
Recurrence Rates of Abscesses [ Time Frame: 30 days after incision and drainage ] [ Designated as safety issue: No ]
Number of patient with a new abscess in same or different location as previous lesion
The primary outcome is clinical cure of abscess at 7 days [ Time Frame: 7 days after incision and drainge ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00822692 on ClinicalTrials.gov Archive Site
Not Provided
Secondary outcome is recurrence rates of abscesses at 30 days. [ Time Frame: 30 days after initial incision and drainage ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates.
Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) 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) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Abscess
  • Methicillin-Resistant Staphylococcus Aureus Infection
  • Drug: Trim/ Sulfa DS
    bactrim DS (800/160) two tablets PO BID x 7 days
    Other Name: Bactrim
  • Drug: placebo
    matched placebo 2 pills PO BID x 7 days
  • Active Comparator: Bactrim DS
    Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days
    Intervention: Drug: Trim/ Sulfa DS
  • Placebo Comparator: matched placebo
    matched placebo 2 pills orally (PO) twice a day (BID) x 7 days
    Intervention: Drug: placebo
Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26. Erratum in: Ann Emerg Med. 2010 Nov;56(5):588.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients age 18-65 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.
  • Additionally, any 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.
  • 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.
  • Finally, patients with sulfa allergy will be excluded.
Both
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00822692
FWH20080055H
No
Not Provided
Not Provided
Gillian Schmitz, Wilford Hall Medical Center
Wilford Hall Medical Center
  • U.S. Air Force Office of the Surgeon General
  • Emergency Medicine Foundation
Principal Investigator: Gillian R Schmitz Wilford Hall Medical Center
Wilford Hall Medical Center
December 2015

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