Saltoglu N, Dalkiran A, Tetiker T, Bayram H, Tasova Y, Dalay C, Sert M
Piperacillin/tazobactam versus imipenem/cilastatin for severe diabetic foot infections: a prospective, randomized clinical trial in a university hospital. [JOURNAL ARTICLE]
Clin Microbiol Infect 2009 Oct 14.
ABSTRACT In this prospective, randomized, and open-label clinical trial, we compared the efficacy and safety of two antibiotic regimens for severe diabetic foot infections (DFI). Sixty-four in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n=30 evaluated) (4.5 g IVq8h) or imipenem/cilastatin (IMP, n=32 evaluated) (0.5 g IVq6h). The mean duration of treatment was 21 days for Pip-Tazo and 24 days for IMP groups. Twenty-two (73.3%) patients in the Pip-Tazo group and 26 (81.2%) patients in the IMP group had DFI associated with osteomyelitis. Clinical response, the primary outcome, was obtained in 14 (46.7%) patients in Pip-Tazo group and in 9 (28.1%) patients in IMP group (relative risk, RR: 1.6 [95% confidence interval, 95%CI: 0.84-3.25], p=0.130).Two patients in the IMP group and none in the PIP-Tazo group relapsed (RR: 2 [0.94-4.24], p=0.058). Eighty-nine microorganisms were isolated; 38 (42%) were Gram-positive and 51(57%) were Gram-negative. Among patients with positive culture, 47 (96%) had complete and 2 (4%) had partial microbiological response. Microbiological response rates were similar in two groups (p=1.000). The amputation was performed in 18 (60%) and 22 (69%) patients in Pip-Tazo and IMP groups (p=0.739). Side effects were more common in the Pip-Tazo group (30% vs. 9.4%), but they were generally mild and reversible. In conclusion, though statistically non-significant given the sample size studied, we showed that Pip-Tazo is superior to IMP in terms of clinical response rate for the treatment of severe DFI. There was no significant difference between treatment groups with regard to microbiological response, relapse and amputation rates.
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