Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection
Primary Purpose
Abscess
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Septra
Sponsored by
About this trial
This is an interventional treatment trial for Abscess focused on measuring abscess, cellulitis, antibiotics, MRSA
Eligibility Criteria
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.
Sites / Locations
- Wilford Hall Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No intervention
Septra DS
Arm Description
No antibiotic
Septra DS (800/160) two pills PO BID x 7 days
Outcomes
Primary Outcome Measures
Clinical Improvement at 7 Days After Incision and Drainage
improving wound without evidence of fever, worsening cellulitis or induration
Secondary Outcome Measures
Recurrence Rates
recurrence of abscess in previous or new location within 30 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00829686
Brief Title
Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection
Official Title
Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
59th Medical Wing
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess
Keywords
abscess, cellulitis, antibiotics, MRSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No antibiotic
Arm Title
Septra DS
Arm Type
Active Comparator
Arm Description
Septra DS (800/160) two pills PO BID x 7 days
Intervention Type
Drug
Intervention Name(s)
Septra
Intervention Description
(800/125) PO BID X 7 days
Primary Outcome Measure Information:
Title
Clinical Improvement at 7 Days After Incision and Drainage
Description
improving wound without evidence of fever, worsening cellulitis or induration
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Recurrence Rates
Description
recurrence of abscess in previous or new location within 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Wilford Hall Medical Center
City
Lackland Air Force Base
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection
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