Piperacillin/tazobactam versus imipenem/cilastatin for severe diabetic foot infections: a prospective, randomized clinical trial in a university hospital

Clin Microbiol Infect. 2010 Aug;16(8):1252-7. doi: 10.1111/j.1469-0691.2009.03067.x. Epub 2009 Oct 14.

Abstract

In this prospective, randomized, open-label clinical trial, we compared the efficacy and safety of two antibiotic regimens for severe diabetic foot infections (DFI). Sixty-two in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n = 30) (4.5 g intravenously every 8h) or imipenem/cilastatin (IMP, n = 32) (0.5 g intravenously every 6h). The mean duration of treatment was 21 days for Pip-Tazo and 24 days for IMP. Twenty-two (73.3%) patients in the Pip-Tazo group and 26 (81.2%) patients in the IMP group had DFI associated with osteomyelitis. Successful clinical response was seen in 14 (46.7%) patients in the Pip-Tazo group and in nine (28.1%) patients in the IMP group [relative risk (RR) 1.6 (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 (43%) Gram-positive and 51(57%) Gram-negative. Among patients 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%) patients in the Pip-Tazo and IMP groups (p 0.739) respectively. Side effects were more common in the Pip-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, Pip-Tazo produced a better clinical response rate than IMP in the treatment of severe DFI. There was no significant difference between the treatment groups with respect to microbiological response, relapse and amputation rates.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Amputation
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Bacteria / classification
  • Bacteria / isolation & purification
  • Bacterial Infections / drug therapy*
  • Cilastatin / adverse effects
  • Cilastatin / therapeutic use*
  • Cilastatin, Imipenem Drug Combination
  • Diabetic Foot / complications*
  • Drug Combinations
  • Female
  • Hospitals, University
  • Humans
  • Imipenem / adverse effects
  • Imipenem / therapeutic use*
  • Male
  • Middle Aged
  • Penicillanic Acid / adverse effects
  • Penicillanic Acid / analogs & derivatives
  • Penicillanic Acid / therapeutic use
  • Piperacillin / adverse effects
  • Piperacillin / therapeutic use
  • Piperacillin, Tazobactam Drug Combination
  • Prospective Studies
  • Recurrence
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Drug Combinations
  • Cilastatin
  • Piperacillin, Tazobactam Drug Combination
  • Imipenem
  • Penicillanic Acid
  • Cilastatin, Imipenem Drug Combination
  • Piperacillin