Vancomycin added to empirical combination antibiotic therapy for fever in granulocytopenic cancer patients. European Organization for Research and Treatment of Cancer (EORTC) International Antimicrobial Therapy Cooperative Group and the National Cancer Institute of Canada-Clinical Trials Group.

A total of 747 febrile granulocytopenic patients with cancer were randomized to receive ceftazidime plus amikacin (CA) with or without vancomycin (V) as initial empirical therapy. Single gram-positive bacteremias responded in 29 (43%) of 68 patients treated with CA and in 48 (72%) of 67 treated with CAV (P = .001). For single gram-negative bacteremias and clinically documented and possible infections the response rates of CA and CAV were 80% and 63% (P = .17), 55% and 75% (P = .009), and 74% and 81% (P = .16), respectively. However, for patients with gram-positive bacteremia and for all other patients, there were no differences by treatment regimens in the proportion of febrile patients on each trial day (P = .85, P = .82, respectively) or in the duration of fever (P = .22, P = .93, respectively). Moreover, no patient with gram-positive bacteremia died during the first 3 days of true empirical therapy. Antibiotic-associated nephrotoxicity was more frequent in patients treated with vancomycin (6% vs. 2%, P = .02). These results do not support the empirical addition of vancomycin to initial antibiotic therapy in cancer patients with fever and granulocytopenia.

RCT Entities:   Population Interventions Outcomes