EFFECTS OF TEICOPLANIN AND THOSE OF VANCOMYCIN IN INITIAL EMPIRICAL ANTIBIOTIC REGIMEN FOR FEBRILE - NEUTROPENIC PATIENTS WITH HEMATOLOGIC MALIGNANCIES

The efficacy and toxicity of teicoplanin and vancomycin in the initial empirical antibiotic regimen in febrile, neutropenic patients with he matologic malignancies were compared in a prospective, randomized, unb linded, multicenter trial in the setting of 29 hematologic units in te rtiary-care or university hospitals. A total of 635 consecutive febril e patients with hematologic malignancies and chemotherapy-induced neut ropenia were randomly assigned to receive intravenously amikacin plus ceftazidime plus either teicoplanin at 6 mg/kg of body weight once dai ly or vancomycin at 1 g twice daily. An efficacy analysis was done for 527 evaluable patients: 275 treated with teicoplanin and 252 treated with vancomycin. Overall, successful outcomes were recorded for 78% of patients who received teicoplanin and 75% of those who were randomize d to vancomycin (difference, 3%; 95% confidence interval [CI], -10 to 4%; P = 0.33). A total of 102 patients presented with primary, single- agent, gram-positive bacteremia. Coagulase-negative staphylococci acco unted for 42%, Staphylococcus aureus accounted for 27%, and streptococ ci accounted for 21% of all gram-positive blood isolates. The overall responses to therapy of gram-positive bacteremias were 92 and 87% for teicoplanin and vancomycin, respectively (difference, 5%; CI, -17 to 6 %; P = 0.22). Side effects, mainly represented by skin rash, occurred in 3.2 and 8% of teicoplanin- and vancomycin-treated patients, respect ively (difference, -4.8%; CI, 0.7 to 8%; P = 0.03); the rate of nephro toxicity was 1.4 and 0.8% for the teicoplanin and vancomycin groups, r espectively (difference, 0.6%; CI, -2 to 1%; P = 0.68). Further infect ions were caused by gram-positive organisms in two patients (0.7%) tre ated with teicoplanin and one patient (0.4%) who received vancomycin ( difference, 0.3%; CI, -0.9 to 1.0%; P = 0.53). Overall mortalities wer e 8.5 and 11% for teicoplanin- and vancomycin-treated patients, respec tively (difference, -2.5%; CI, -2 to 7%; P = 0.43); death was caused b y primary gram-positive infections in three patients (1%) in each trea tment group. When used for initial empirical antibiotic therapy in feb rile, neutropenic patients, teicoplanin was at least as efficacious as vancomycin, but it was associated with fewer side effects.