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

59th Medical Wing

Status: Completed

Conditions: Methicillin-Resistant Staphylococcus Aureus Infection; Abscess

Treatments: Drug: placebo; Drug: Trim/ Sulfa DS

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00822692

FWH20080055H

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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139 participants in 2 patient groups, including a placebo group

Bactrim DS

Active Comparator group

Description:

Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days

Treatment:

Drug: Trim/ Sulfa DS

matched placebo

Placebo Comparator group

Description:

matched placebo 2 pills orally (PO) twice a day (BID) x 7 days

Treatment:

Drug: placebo