Multicenter clinical trial of cefoperazone sodium in the United States.
A total of 187 physician investigators throughout the United States participated in a multicenter trial to evaluate the safety and efficacy of a twice daily dosage of cefoperazone sodium; 91 percent of patients received a dosage of 4 g or less of cefoperazone per day. A total of 455 patients were included in the evaluation of efficacy: 100 patients with lower respiratory tract infection; 146 patients with skin and soft tissue infection; 14 patients with osteomyelitis; 18 patients with obstetric and gynecologic infections; 84 patients with urinary tract infection; and 44 patients with bacteremia. Overall, treatment achieved a satisfactory clinical outcome in 95.3 percent of these patients. Side effects of cefoperazone were evaluated in 659 patients. Prothrombin time increased during therapy in 4 percent of patients, all but one of whom was more than 65 years old. Prothrombin time became normal with the administration of vitamin K. Diarrhea (4 or more loose stools a day) was observed in 3 percent of patients. Other adverse reactions including leukopenia, elevation of serum liver enzyme levels, and eosinophilia were mild, reversible, and typical of beta-lactam antibiotics. These results suggest that (1) twice daily administration of cefoperazone sodium can be used to treat a variety of bacterial infections caused by susceptible pathogens; (2) the adverse reactions associated with this agent at the dosage schedule employed in this trial (2 g twice a day) are predictable and limited; (3) multicenter trials of this type allow for rapid collection of data regarding safety and efficacy of new antibiotics.
D000368:Aged; D001424:Bacterial Infections / Q000188:drug therapy*; D002438:Cefoperazone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003428:Cross Infection / Q000188:drug therapy; D004334:Drug Administration Schedule; D005260:Female; D005831:Genital Diseases, Female / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010019:Osteomyelitis / Q000188:drug therapy; D012141:Respiratory Tract Infections / Q000188:drug therapy; D018805:Sepsis / Q000188:drug therapy; D012874:Skin Diseases, Infectious / Q000188:drug therapy; D014481:United States; D014552:Urinary Tract Infections / Q000188:drug therapy
D002438:Cefoperazone