Sulbactam/cefoperazone versus cefotaxime for the treatment of moderate-to-severe bacterial infections: results of a randomized, controlled clinical trial.
Author(s): Li JT, Lu Y, Hou J, Chen YF, Miao JZ, Jia YX, Hou J, Zhang XZ, Chen DK, Hu WZ, Li LJ, Liu DM, Wang Z, Wu J, Gu JM, Wang HL, Zhang YL, Sun L
Affiliation(s): Institute of Clinical Pharmacology, Beijing Medical University, and Beijing Hospital, People's Republic of China.
Publication date & source: 1997-03, Clin Infect Dis., 24(3):498-505.
Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial
We conducted a randomized, open-label, controlled, multicenter study to 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 recovered from these patients produced beta-lactamase. Two hundred-seven (88.1%) of the 235 patients enrolled completed the study and were included in the efficacy and safety evaluations. One hundred-three patients received sulbactam/cefoperazone (2-4 g/d) administered in evenly divided doses every 12 hours by a 30-minute intravenous drip; 104 patients received cefotaxime (6-12 g/d) administered in evenly divided doses every 6 or 8 hours by a 30-minute intravenous drip. The overall efficacy 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/cefoperazone group and 81% for the cefotaxime group (P = .467). Both drug regimens were well tolerated. Sulbactam/cefoperazone is effective and safe for the treatment of moderate-to-severe bacterial infections caused mainly by beta-lactamase-producing organisms.