SULBACTAM CEFOPERAZONE VERSUS CEFOTAXIME FOR THE TREATMENT OF MODERATE-TO-SEVERE BACTERIAL-INFECTIONS - RESULTS OF A RANDOMIZED, CONTROLLEDCLINICAL-TRIAL/

We conducted a randomized, open-label, controlled, multicenter study t o compare sulbactam/cefoperazone with cefotaxime in terms of efficacy and safety for the treatment of hospitalized patients with moderate-to -severe bacterial infections. More than two-thirds of the pathogens re covered from these patients produced beta-lactamase. Two hundred-seven (88.1%) of the 235 patients enrolled completed the study and were inc luded in the efficacy and safety evaluations. One hundred-three patien ts received sulbactam/cefoperazone (2-4 g/d) administered in evenly di vided doses every 12 hours by a 30-minute intravenous drip; 104 patien ts received cefotaxime (6-12 gld) administered in evenly divided doses every 6 or 8 hours by a 30-minute intravenous drip. The overall effic acy rates (i.e., cure or markedly improved) were 95% for the sulbactam /cefoperazone group and 90% for the cefotaxime group (P=.186), whereas the bacterial eradication rates were 85% for the sulbactam/cefoperazo ne group and 81% for the cefotaxime group (P=.467). Bath drug regimens were well tolerated. Sulbactam/cefoperazone is effective and safe for the treatment of moderate-to-severe bacterial infections caused mainl y by beta-lactamase-producing organisms.