A prospective, randomized, double-blind multicenter comparison of parenteral ertapenem and XXXX for the treatment of hospitalized adults with @entity497 .

@entity1 @entity2756 @entity3405 @entity497 @entity328
BACKGROUND: Ertapenem is a once-daily parenteral @entity3405 licensed in the United States in November 2001 and in Europe in May 2002. OBJECTIVE: This study compared the efficacy and safety profiles of ertapenem with those of @entity2756 for the treatment of hospitalized adult @entity1 with serious @entity497 ( @entity497 ) requiring parenteral therapy. METHODS: In this prospective, double-blind (with sponsor blinding), multicenter study, adult @entity1 with @entity497 were stratified by Pneumonia Severity Index (< or = 3 or > 3) and age (< or = 65 or > 65 years) and randomized (2:1) to receive IV or intramuscular (IM) ertapenem 1 g once daily or IV or IM @entity2756 1 g once daily. Investigators could switch @entity1 to an oral antimicrobial agent if clinical improvement was shown after at least 3 days of parenteral therapy. RESULTS: A total of 364 @entity1 were randomized to treatment: 239 to the ertapenem group and 125 to the @entity2756 group. Three @entity1 in the ertapenem group and 2 in the @entity2756 group did not receive study therapy. Of the treated @entity1 , 77.1% (182/236) of @entity1 in the ertapenem group and 75.6% (93/123) in the @entity2756 group were clinically evaluable. Among clinically evaluable @entity1 , the mean (SD) durations of parenteral and total (parenteral plus optional oral) therapy were 5.5 (2.6) and 11.5 (2.7) days for ertapenem and 5.6 (2.8) and 11.7 (3.0) days for @entity2756 , respectively. @entity328 was the most frequently isolated pathogen in both treatment groups. Cure rates were 92.2% for clinically evaluable @entity1 in the ertapenem group and 93.6% for those in the @entity2756 group (95% CI for the difference, adjusted for stratum, -8.6 to 5.7), fulfilling the criteria for statistical equivalence. At completion of parenteral therapy, 94.7% of @entity1 in the ertapenem group and 95.8% in the @entity2756 group showed clinical improvement. Infused vein complications (ertapenem, 3.4% [8/236]; @entity2756 , 7.3% [9/123]) and elevated transaminase levels (ertapenem, 6.3% [13/207]; @entity2756 , 7.1% [8/113]) were the most common adverse events in both groups. CONCLUSIONS: In this study of hospitalized adult @entity1 , ertapenem therapy, with an oral switch option, was as effective as @entity2756 with the same oral switch option for treatment of @entity497 requiring initial parenteral therapy. The overall safety profiles of the 2 drugs were comparable.
