2 A DOUBLE-BLIND COMPARISON OF EMPIRICAL.pdf

Volume 341 Number 5 · 305 The New England Journal of Medicine ? Copyr ight, 1999, by the Massachusetts Medical Society VOLUME 341 J ULY 29, 1999 NUMBER 5 A DOUBLE-BLIND COMPARISON OF EMPIRICAL ORAL AND INTRAVENOUS ANTIBIOTIC THERAPY FOR LOW-RISK FEBRILE PATIENTS WITH NEUTROPENIA DURING CANCER CHEMOTHERAPY A LISON F REIFELD , M.D., D ONNA M ARCHIGIANI , R.N., T HOMAS W ALSH , M.D., S TEPHEN C HANOCK , M.D., L INDA L EWIS , M.D., J OHN H IEMENZ , M.D., S HARON H IEMENZ , R.N., J EANNE E. H ICKS , M.D., V EE G ILL , P H .D., S ETH M. S TEINBERG , P H .D., AND P HILIP A. P IZZO , M.D. A BSTRACT Background Among patients with fever and neu- tropenia during cancer chemotherapy who have a low risk of complications, oral administration of em- pirical broad-spectrum antibiotics may be an accept- able alternative to intravenous treatment. Methods We conducted a randomized, double- blind, placebo-controlled study of patients (age, 5 to 74 years) who had fever and neutropenia during che- motherapy for cancer. Neutropenia was expected to be present for no more than 10 days in these pa- tients, and they had to have no other underlying con- ditions. Patients were assigned to receive either oral ciprofloxacin plus amoxicillin–clavulanate or intrave- nous ceftazidime. They were hospitalized until fever and neutropenia resolved. Results A total of 116 episodes were included in each group (84 patients in the oral-therapy group and 79 patients in the intravenous-therapy group). The mean neutrophil counts at admission were 81 per cubic millimeter and 84 per cubic millimeter, re- spectively; the mean duration of neutropenia was 3.4 and 3.8 days, respectively. Treatment was successful without the need for modifications in 71 percent of episodes in the oral-therapy group and 67 percent of episodes in the intravenous-therapy gro