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 chemo-induced neutropenia. In this setting, empirical administration of broad spectrum antibiotics must be rapid. The aim of this work was to compare, for the first time, cefpirome (CPO) and piperacillin-tazobactam (PT) in a large randomized trial. Two hundred-eight febrile neutropenic episodes (FNE) (> or = 38.5 degrees C and ANC < or = 0.5 giga/l) were treated by randomization, as first line therapy, using either CPO 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 (median: 49) who received chemotherapy (n = 160) or allogeneic (n = 10) or autologous (n = 38) stem cell transplantations. Underlying diseases were: acute leukemia (n = 131), lymphoma (n = 33), myeloma (n = 16), solid tumor (n = 8), myeloproliferative disorder (n = 9), chronic lymphoid leukemia (n = 5), aplastic anemia (n = 3), myelodysplasia (n = 3). Distribution of age, neutropenia duration (median: 17 days), underlying disease, and protocol therapy duration (median: 11 days) was comparable in both arms. A microbiologically documented infection (MDI) was evidenced in 57 cases (27%). Bacteria were isolated from blood cultures in 54 cases (Gram positive: 32 cases). Their in vitro susceptibility rates to CPO and PT were not different. Two days after antibiotics initiation, clinical (fever disappearance) and microbiological (culture negativation) 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 superinfection) was 59% with CPO versus 50% with PT (p = 0.27) and 53% versus 40% respectively in the 151 cases with neutropenia > or = 10 days (p = 0.17). The occurrence of side effects was similar in both arms. In our hands, the efficacy of CPO and PT was comparable for treating FNE.
Bauduer
F
F
Hematology Department, CHI Bayonne, France.
Cousin
T
T
Boulat
O
O
Rigal-Huguet
F
F
Molina
L
L
Fegueux
N
N
Jourdan
E
E
Boiron
J M
JM
Reiffers
J
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000741:Anemia, Aplastic / Q000150:complications; D002511:Cephalosporins / Q000191:economics / Q000627:therapeutic use*; D004791:Enzyme Inhibitors / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D005602:France; D019337:Hematologic Neoplasms / Q000150:complications*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000150:complications; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D010397:Penicillanic Acid / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use*; D010878:Piperacillin / Q000191:economics / Q000627:therapeutic use*; D000078142:Tazobactam; D016896:Treatment Outcome; D000097572:Cefpirome
D002511:Cephalosporins; D004791:Enzyme Inhibitors; D010397:Penicillanic Acid; D010878:Piperacillin; D000078142:Tazobactam; D000097572:Cefpirome