NCT00973765

Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses

Randomized Placebo-Controlled Trial of Bactrim on 7 Day Outcome in Emergency Department Patients With Uncomplicated Abscesses at Risk for Community Acquired Methicillin Resistant Staph Aureus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: 59th Medical Wing · Federal
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.

Conditions

• Abscesses

Interventions

Type	Name	Description
DRUG	bactrim	bactrim DS (800/160) 2 pills PO BID x 7 days
DRUG	placebo	placebo 2 pills po BID x 7 days

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-09-09
• Last updated: 2010-03-09
• Results posted: 2010-03-02

Locations

1 site across 1 country: United States