Prospective, non-comparative study of XXXX for the treatment of superficial and deep incisional surgical site @entity281 .

@entity1 @entity3256 @entity794 @entity281 @entity13757 @entity272 @entity1011 @entity204
BACKGROUND: @entity272 , including surgical site @entity281 (SSIs), usually involve gram-positive pathogens and continue to be a leading cause of morbidity and @entity204 among hospital @entity1 . The increasing prevalence of @entity3256 -resistant @entity794 and other resistant strains accentuates the need for effective and safe therapies for such @entity281 . This exploratory study evaluated the efficacy and safety of @entity13757 in @entity1 with gram-positive SSI according to wound classification. METHODS: Eligible @entity1 had an SSI with onset < 30 days after surgery, positive gram stain or culture at least three days before @entity13757 therapy began, and three or more clinical signs and symptoms of @entity281 . The incisional SSI was classified as superficial or deep according to the U.S. Centers for Disease Control and Prevention criteria. @entity1 with organ-space @entity281 were excluded, as were those with major concomitant @entity281 , foreign material in the incision that could not be removed, previous systemic antimicrobial therapy, or @entity1011 clearance < 30 mL/min. @entity13757 4   mg/kg was administered intravenously once daily for 7-14 days. The primary efficacy endpoint was clinical response at the end of @entity13757 therapy, and the safety assessment was based on adverse events (AEs). RESULTS: Sixty-nine @entity1 were enrolled, 60 of whom were evaluable for efficacy. Extremity wounds predominated among superficial incisional SSIs (n = 30), whereas abdominal wounds predominated among deep SSIs (n = 30). @entity1 with deep incisional SSI were more likely to be young, male, white, and febrile and to weigh more than @entity1 with superficial SSIs. The overall clinical success rate was 92% (95% confidence interval [CI] 82-97%); the success rate was 100% in superficial incisional SSI and 83% in deep SSI (17% difference; 95% CI 0-33%). @entity794 (28/36 @entity3256 -resistant) was the pathogen isolated most frequently. In 10 @entity1 who were febrile at baseline, the median time to defervescence was five days, and the mean duration of treatment in the series was 11.2 days. @entity13757 was well tolerated. In most @entity1 , AEs were mild or moderate in intensity; in two @entity1 (one superficial, one deep), @entity13757 was discontinued because of AEs. CONCLUSIONS: The results of this exploratory study of SSI are consistent with those of previous studies of @entity13757 in the treatment of diverse complicated skin and skin-structure @entity281 , and suggest that wound classification should be treated as an important covariate in future studies of @entity13757 and other antibiotics.
