Background: Soft tissue and bone infections of the lower limb continue to be a frequent and
serious complication in patients with diabetes mellitus. The best choice of antimicrobial for
the empiric treatment of moderate to severe diabetic foot infections has not been established
clearly.
Methods: We conducted a prospective, randomized, open-label, multicenter trial comparing
piperacillin/tazobactam (P/T) (4 g/0.5 g q8h) and ampicillin/sulbactam (A/S) (2 g/1 g q6h)
as a parenteral treatment for 314 adult patients with moderate-to-severe infected diabetic foot
ulcers. Patients with polymicrobial infections involving methicillin-resistant Staphylococcus
aureus also received vancomycin 1 g q12h.
Results: Clinical efficacy rates (cure or improvement) were statistically equivalent overall
(81% for P/T vs. 83.1% for A/S), and median duration of treatment was similar in the clinically
evaluable populations (nine days for P/T, 10 days for A/S). Drug-related adverse events
for both study drugs were comparable in frequency and type.
Conclusions: Although both study drugs provide safe and effective empiric treatment for
moderate-to-severe infected diabetic foot ulcers, piperacillin/tazobactam has the advantage of
covering Pseudomonas aeruginosa (bacteriologic success rate of 85.7%), the most commonly
isolated gram-negative pathogen in this study.
