USE OF AMPICILLIN SULBACTAM VERSUS IMIPENEM/CILASTATIN IN THE TREATMENT OF LIMB-THREATENING FOOT INFECTIONS IN DIABETIC-PATIENTS/

In a double-blind randomized trial, imipenem/cilastatin (I/C; 500 mg e very 6 hours) and ampicillin/sulbactam (A/S; 3 g every 6 hours) were c ompared in regard to their efficacy for initial empirical and definiti ve parenteral treatment of limb-threatening pedal infection in diabeti c patients. The major endpoints of treatment were cure (resolution of soft-tissue infection), failure (inadequate improvement, necessitating a change in antibiotic therapy), and eradication (clearance of all pa thogens from the wound and any bone cultures). Patients in the two tre atment groups were similar in regard to the severity of diabetes; pres ence of neuropathy and peripheral vascular disease; site and severity of infection; pathogen isolated; and frequency of osteomyelitis (assoc iated with 68% of the 48 A/S-treated infections and 56% of the 48 I/C- treated infections). After 5 days of empirical treatment, improvement was noted in 94% of the A/S and 98% of the I/C recipients. At the end of definitive treatment (days' duration [mean +/- SD]: 13 +/- 6.5 [A/S ], 14.8 +/- 8.6 [I/C]), outcomes were similar: cure, 81% (A/S) vs. 85% (I/C); failure, 17% (A/S) vs. 13% (I/C); and eradication, 67% (A/S) v s. 75% (I/C). Treatment failures were associated with the presence of antibiotic-resistant pathogens and possible nosocomial acquisition of infections. The number of adverse events among patients in the two tre atment groups was similar: 7 in the A/S group (4 had diarrhea and 3 ha d rash) and 9 in the I/C group (5 had diarrhea, 2 had severe nausea, 1 had rash, and 1 had seizure). Efficacy of A/S and I/C is similar for initial empirical and definitive treatment of limb-threatening pedal i nfection in patients with diabetes.