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

• Published in: Clinical microbiology and infection Vol. 16; no. 8; pp. 1252 - 1257
• Main Authors: Saltoglu, N., Dalkiran, A., Tetiker, T., Bayram, H., Tasova, Y., Dalay, C., Sert, M.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Elsevier Ltd 01.08.2010; Blackwell Publishing Ltd; Wiley-Blackwell; Elsevier Limited
• Subjects: Adult; Aged; Aged, 80 and over; Amputation; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Antibacterial agents; Antibiotics; Antibiotics. Antiinfectious agents. Antiparasitic agents; Associated diseases and complications; Bacteria - classification; Bacteria - isolation & purification; Bacterial Infections - drug therapy; Biological and medical sciences; Cilastatin; Cilastatin - adverse effects; Cilastatin - therapeutic use; Clinical trials; Diabetes; Diabetes mellitus; Diabetes. Impaired glucose tolerance; Diabetic Foot - complications; diabetic foot infection; Drug Combinations; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Female; Foot; Foot diseases; Hospitals; Hospitals, University; Humans; imipenem; Imipenem - adverse effects; Imipenem - therapeutic use; Infection; Infectious diseases; Inosine monophosphate; Male; Medical sciences; Medical treatment; Microorganisms; Middle Aged; Osteomyelitis; Penicillanic Acid - adverse effects; Penicillanic Acid - analogs & derivatives; Penicillanic Acid - therapeutic use; Pharmacology. Drug treatments; piperacillin; Piperacillin - adverse effects; Piperacillin - therapeutic use; piperacillin-tazobactam; Prospective Studies; Recurrence; Risk assessment; Side effects; Statistics; tazobactam; Time Factors; Treatment Outcome; piperacillin; imipenem; tazobactam; diabetic foot infection; Cilastatin; Endocrinopathy; Skin disease; Diabetic Foot; β-Lactamase; Penicillin derivatives; Carbapenem derivatives; Piperacillin; Disease of the foot; Clinical trial; Hospital; Nervous system diseases; Enzyme; β-Lactams; Diabetes mellitus; Enzyme inhibitor; Infection; Peptidases; Antibiotic; Tazobactam; Hydrolases; Antibacterial agent; Comparative study; Imipenem
• ISSN: 1198-743X; 1469-0691
• DOI: 10.1111/j.1469-0691.2009.03067.x

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.