Combination of amikacin and carbenicillin with or without cefazolin as empirical treatment of febrile neutropenic patients. The International Antimicrobial Therapy Project Group of the European Organization for Research and Treatment of Cancer.

A total of 841 febrile neutropenic patients from 20 centers were randomized to receive carbenicillin (or ticarcillin) plus amikacin or these antibiotics plus cefazolin to compare outcome and incidence of nephrotoxicity. Infection with Escherichia coli, Klebsiella species, Pseudomonas aeruginosa, or Staphylococcus aureus accounted for most of the microbiologically documented febrile episodes. The response to therapy was similar in the two treatment groups for all infections and for bacteremia. Improvement occurred in 35 (64%) of 55 bacteremic patients treated with two antibiotics and 39 (65%) of 60 treated with three antibiotics. An increase in serum creatinine to 2 mg/dL over baseline occurred in eight (2.1%) of 381 patients in the former and in 50 (2.4%) of 364 patients in the latter group. Thus, the two antibiotic regimens were equal in efficacy and in nephrotoxicity. Although not the primary focus of this study, a significant decrease in incidence of infection, including bacteremias, was found in neutropenic patients treated with any oral intestine decontamination regimen.

RCT Entities:   Population Interventions Outcomes