XXXX / @entity7120 versus imipenem/cilastatin for severe @entity6 : a prospective, randomized clinical trial in a university hospital.

@entity1 @entity2892 @entity6 @entity4034 @entity9234 @entity7120 @entity4552 @entity3400 @entity15129
In this prospective, randomized, open-label clinical trial, we compared the efficacy and safety of two antibiotic regimens for severe @entity6 ( @entity6 ). Sixty-two in- @entity1 with @entity6 received either @entity3400 / @entity7120 ( @entity4552 -Tazo, n = 30) (4.5 g intravenously every 8h) or @entity2892 / @entity9234 ( @entity15129 , n = 32) (0.5 g intravenously every 6h). The mean duration of treatment was 21 days for @entity4552 -Tazo and 24 days for @entity15129 . Twenty-two (73.3%) @entity1 in the @entity4552 -Tazo group and 26 (81.2%) @entity1 in the @entity15129 group had @entity6 associated with @entity4034 . Successful clinical response was seen in 14 (46.7%) @entity1 in the @entity4552 -Tazo group and in nine (28.1%) @entity1 in the @entity15129 group [relative risk (RR) 1.6 (95% CI 0.84-3.25), p 0.130]. Two @entity1 in the @entity15129 group and none in the @entity4552 -Tazo group relapsed [RR 2 (0.94-4.24), p 0.058]. Eighty-nine microorganisms were isolated: 38 (43%) Gram-positive and 51(57%) Gram-negative. Among @entity1 with positive culture, 47 (96%) had complete and two (4%) had partial microbiological response. Microbiological response rates were similar in both groups (p 1.000). Amputation was performed in 18 (60%) and 22 (69%) @entity1 in the @entity4552 -Tazo and @entity15129 groups (p 0.739) respectively. Side effects were more common in the @entity4552 -Tazo group (30% vs. 9.4%), but they were generally mild and reversible. In conclusion, although the sample size was small and the results did not reach statistical significance, @entity4552 -Tazo produced a better clinical response rate than @entity15129 in the treatment of severe @entity6 . There was no significant difference between the treatment groups with respect to microbiological response, relapse and amputation rates.
