Sulbactam/cefoperazone versus cefotaxime for the treatment of moderate-to-severe bacterial infections: results of a randomized, controlled clinical 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.
Li
J T
JT
Institute of Clinical Pharmacology, Beijing Medical University, and Beijing Hospital, People's Republic of China.
Lu
Y
Y
Hou
J
J
Chen
Y F
YF
Miao
J Z
JZ
Jia
Y X
YX
Hou
J
J
Zhang
X Z
XZ
Chen
D K
DK
Hu
W Z
WZ
Li
L J
LJ
Liu
D M
DM
Wang
Z
Z
Wu
J
J
Gu
J M
JM
Wang
H L
HL
Zhang
Y L
YL
Sun
L
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D001419:Bacteria / Q000187:drug effects / Q000302:isolation & purification; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D002438:Cefoperazone / Q000494:pharmacology / Q000627:therapeutic use*; D002439:Cefotaxime / Q000494:pharmacology / Q000627:therapeutic use*; D002511:Cephalosporins / Q000494:pharmacology / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors; D005260:Female; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D012141:Respiratory Tract Infections / Q000188:drug therapy; D017192:Skin Diseases, Bacterial / Q000188:drug therapy; D013407:Sulbactam / Q000494:pharmacology / Q000627:therapeutic use*; D014552:Urinary Tract Infections / Q000188:drug therapy; D065093:beta-Lactamase Inhibitors
D002511:Cephalosporins; D004791:Enzyme Inhibitors; D065093:beta-Lactamase Inhibitors; D002438:Cefoperazone; D002439:Cefotaxime; D013407:Sulbactam