A randomized prospective multicentre trial of cefpirome versus piperacillin-tazobactam in febrile neutropenia

Fever is frequently the only clinical sign of infection in patients with ch emo-induced neutropenia. In this setting, empirical administration of broad spectrum antibiotics must be rapid. The aim of this work was to compare, f or the first time, cefpirome (CPO) and piperacillin-tazobactam (PT) in a la rge randomized trial. Two hundred-eight febrile neutropenic episodes (FNE) (greater than or equal to 38,5 degreesC and ANC less than or equal to 0.5 g iga/l) were treated by randomization, as first line therapy, using either C PO 2 g x 2/day (105 cases) or PT 4 g x 3/day (103 cases), alone (CPO:15/PT: 15), or plus aminoglycoside (165 cases, CPO: 82/PT: 83) or quinolone CPO: 2/PT: 2). There were 131 men and 77 women aged between 17 and 83 years (med ian: 49) who received chemotherapy (n=160) or allogeneic (n=10) or autologo us (n=38) stem cell transplantations. Underlying diseases were: acute leuke mia (n=131), lymphoma (n=33), myeloma (n=16), solid tumor (n=8), myeloproli ferative disorder (n=9), chronic lymphoid leukemia (n=5), aplastic anemia ( n=3), myelodysplasia (n=3). Distribution of age, neutropenia duration (medi an: 17 days), underlying disease, and protocol therapy duration (median: 11 days) was comparable in both arms. A microbiologically documented infectio n (MDI) was evidenced in 57 cases (27%). Bacteria were isolated from blood cultures in 54 cases (Gram positive: 32 cases). Their in vitro susceptibili ty rates to CPO and PT were not different. Two days after antibiotics initi ation, clinical (fever disappearance) and microbiological (culture negativa tion) success rates (SR) were 62% for CPO versus 61% for PT and 50% versus 55% respectively in case of MDI (p = 0.89). Two deaths and 77 failures were registered. At the end of protocol, SR (no antibiotic change/absence of su perinfection) was 59% with CPO versus 50% with FI(p = 0.27) and 53% versus 40% respectively in the 151 cases with neutropenia greater than or equal to 10 days (p = 0.17). The occurrence of side effects was similar in both arm s. In our hands, the efficacy of CPO and PT was comparable for treating FNE .