title: Sulbactam/cefoperazone versus cefotaxime for the treatment of moderate-to-severe bacterial infections: results of a randomized, controlled clinical trial.
abstract: 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.
authors.affiliation: Institute of Clinical Pharmacology, Beijing Medical University, and Beijing Hospital, People's Republic of China.
authors.forename: J T
authors.initials: JT
authors.lastname: Li
authors.forename: Y
authors.initials: Y
authors.lastname: Lu
authors.forename: J
authors.initials: J
authors.lastname: Hou
authors.forename: Y F
authors.initials: YF
authors.lastname: Chen
authors.forename: J Z
authors.initials: JZ
authors.lastname: Miao
authors.forename: Y X
authors.initials: YX
authors.lastname: Jia
authors.forename: J
authors.initials: J
authors.lastname: Hou
authors.forename: X Z
authors.initials: XZ
authors.lastname: Zhang
authors.forename: D K
authors.initials: DK
authors.lastname: Chen
authors.forename: W Z
authors.initials: WZ
authors.lastname: Hu
authors.forename: L J
authors.initials: LJ
authors.lastname: Li
authors.forename: D M
authors.initials: DM
authors.lastname: Liu
authors.forename: Z
authors.initials: Z
authors.lastname: Wang
authors.forename: J
authors.initials: J
authors.lastname: Wu
authors.forename: J M
authors.initials: JM
authors.lastname: Gu
authors.forename: H L
authors.initials: HL
authors.lastname: Wang
authors.forename: Y L
authors.initials: YL
authors.lastname: Zhang
authors.forename: L
authors.initials: L
authors.lastname: Sun
mesh_terms: 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
chemical_list: D002511:Cephalosporins; D004791:Enzyme Inhibitors; D065093:beta-Lactamase Inhibitors; D002438:Cefoperazone; D002439:Cefotaxime; D013407:Sulbactam