Clinical Trial: Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Brief Summary:
The primary aim of this study is to quantify the effectiveness of Bactrim as additional therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard therapy plus Bactrim, versus standard therapy plus placebo.
The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence, subjects treated with standard therapy plus Bactrim will have higher cure rates than those treated with standard therapy plus placebo.
Detailed Summary:
Sponsor: Brigham and Women's Hospital
Current Primary Outcome: Relative Efficacy [ Time Frame: 12 +/- 2 days; 30 +/- 2 days ]
Proportion of subjects in each arm with successful treatment.
Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days.
Original Primary Outcome: The main outcome measure will be the relative efficacy of treatment in the two treatment arms: (a) standard therapy plus Bactrim, (b) standard therapy plus placebo. [ Time Frame: 14 days; 30 days ]
Current Secondary Outcome: Progression to Abscess [ Time Frame: 12 +/- 2 days, 30 days +/- 2 days ]
Original Secondary Outcome:
Information By: Brigham and Women's Hospital
Dates:
Date Received: December 28, 2007
Date Started: May 2007
Date Completion:
Last Updated: August 12, 2012
Last Verified: August 2012
