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

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.

Diagnosis, Treatment and Prevention of Diabetic Foot Wounds and Infections: Turkish Consensus Report

“…[15] Debridmanla infekte dokunun tamamen temizlenmesi mümkün olmadığında ve hastanın kalan infeksiyon yü-küyle başa çıkamayacağı durumlarda, infeksiyon bulunmayan güvenli bir düzeyden ampütasyon yapılması yaşam kurtarıcı olacaktır. [16] DA yarası olan bir hastada önemli bir arteriyel yetersizlik olduğu düşünülüyorsa, bunun erken tanınması ve girişimsel tedavisi gerekir. [17] Hiperbarik oksijen tedavisi, DAİ'lerde tek başına değil, diğer tedavilerle birlikte bir yardım-cı tedavi yöntemi olarak kullanılır.…”

“…[15] When the infected tissue cannot be completely cleared with the debridement and in cases when the patient could not cope with the remaining infection load, performing a limb amputation on a safe level of infection would be lifesaving. [16] If an arterial insufficiency is considered in a patient with a DF wound, early diagnosis and interventional treatment is necessary. [17] Hyperbaric oxygen therapy is used as an adjunctive treatment in combination with other treatments in DFI patients.…”

In Vitro Spectrum of Pexiganan Activity When Tested against Pathogens from Diabetic Foot Infections and with Selected Resistance Mechanisms

“…In moderate to severe infections, S. aureus, Streptococcus spp., members of the family Enterobacteriaceae, and obligate anaerobes are the common bacterial pathogens (6). In a prospective randomized clinical trial of severe DFI, enterococci and Pseudomonas aeruginosa occurred in approximately 10 and 20% of patients, respectively (7). Pexiganan has been shown to have activity against many of the abovementioned pathogens (8)(9)(10).…”

Biofilm and Diabetic Foot Infections

“…Biyofilm oluşum basamakları şunlardan oluşur: [1] Yü-zeye geri dönüşümlü bağlanma; [2] yüzeye geri dönüşümsüz bağlanma; [3] mikrokoloni oluşumu; [4] olgun biyofilm oluşu-mu; [5] planktonik hücrelerin biyofilmden kopması.…”

“…Diyabet hastalarında yaşam boyunca %15-25 oranın-da diyabetik ayak ülseri gelişmektedir (1). Diyabetik ayak infeksiyonu, diyabetin en önemli mortalite ve morbidite nedenlerinden biridir; uzuv ampütasyonlarının da en sık nedenlerinden birini oluşturmaktadır.…”