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Trimethoprim-Sulfamethoxazole versus Placebo for Uncomplicated Skin Abscess

David A. Talan, M.D., William R. Mower, M.D., Ph.D., Anusha Krishnadasan, Ph.D., Fredrick M. Abrahamian, D.O., Frank Lovecchio, D.O., David J. Karras, M,D., Mark T. Steele, M.D., Richard E. Rothman, M.D., Ph.D., Rebecca Hoagland, M.S., Gregory J. Moran, M.D.

N Engl J Med 2016; 374: 823-32| March 2, 2016 | DOI: 10.1056/NEJMoa1507476

U.S. emergency department visits for cutaneous abscess have increased with the emergence of methicillin-resistant Staphylococcus aureus (MRSA). The role of antibiotics for patients with a drained abscess is unclear.

We conducted a randomized trial at five U.S. emergency departments to determine whether seven-days of trimethoprim-sulfamethoxazole (320mg/1600mg twice daily) is superior to placebo for outpatients age >12 years with an uncomplicated abscess receiving drainage. The primary outcome was clinical cure of the abscess assessed 7-14 days after treatment. 

Subjects were median age 35 years (range, 14-73); 45.3% of abscesses grew MRSA. In the modified intention-to-treat population, clinical cure of the abscess occurred in 507 of 630 (80.5%) trimethoprim-sulfamethoxazole treated versus 454 of 617 (73.6%) placebo treated subjects (difference 6.9 percentage points; 95% CI 2.1%, 11.7%, p=0.0046). In the per-protocol population, the trimethoprim-sulfamethoxazole group had improved secondary outcomes compared to the placebo group including fewer subsequent surgical drainage procedures (3.4% vs. 8.6%; difference -5.2 percentage points; 95% CI -8.2%, -2.2%), new site skin infections (3.1% vs. 10.3%; difference -7.2 percentage points, 95% CI -10.4%, -4.1%), and infections in household members (1.7% vs. 4.1%, difference -2.4 percentage points, 95% CI -4.6%, -0.2%) 7-14 days after treatment. Trimethoprim-sulfamethoxazole was associated with slightly more, mostly mild, gastrointestinal side effects. Through 7-14 days after treatment, invasive infections developed in 2 (0.4%) trimethoprim-sulfamethoxazole-treated subjects and 2 (0.4%) placebo-treated subjects, and through 42-56 days after treatment, in one (0.2%) trimethoprim sulfamethoxazole-treated subject.

In settings where MRSA was prevalent, trimethoprim-sulfamethoxazole treatment produced higher abscess cure rates than placebo. (ClinicalTrials.gov number, NCT00729937).

Originally Appeared in The New England Journal of Medicine on March 2, 2016.

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