Cefoperazone versus cefotaxime, plus amikacin or sisomicin, in fever and infection in hematologic granulocytopenic patients.
Forty patients with leukemia or aplastic anemia were randomized to receive one of the following antibiotic regimens at the onset of fever during granulocytopenia: cefoperazone + amikacin (regimen A), cefoperazone + sisomicin (regimen B), cefotaxime + amikacin (regimen C), cefotaxime + sisomicin (regimen D). All patients were receiving gut decontamination at the time of randomization. Patients were monitored twice weekly with swabs and cultures for bacteria and fungi. Overall, there were 56 febrile episodes: 31 were proven bacterial, 3 were probable, and 16 were of unknown origin. Response rates were comparable in all 4 treatment regimens: 90%, 91%, 92% and 92%, respectively. Three patients died of bacterial infections (2 Gram+, 1 Gram-), one patient died with probable infection, 6 febrile episodes were related to fungal infection (Candida), and 2 patients died. The mortality rate was comparable in all groups. Two patients died of renal failure. Abnormalities in liver function tests were observed, but were without consequences. There were no statistical differences in renal-hepatic toxicity in the 4 arms.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000380:Agranulocytosis / Q000150:complications*; D000583:Amikacin / Q000627:therapeutic use*; D000741:Anemia, Aplastic / Q000150:complications; D002438:Cefoperazone / Q000627:therapeutic use*; D002439:Cefotaxime / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007165:Immunosuppression Therapy / Q000009:adverse effects; D007239:Infections / Q000188:drug therapy* / Q000209:etiology; D007612:Kanamycin / Q000031:analogs & derivatives*; D007938:Leukemia / Q000150:complications; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D012853:Sisomicin / Q000627:therapeutic use*
D007612:Kanamycin; D002438:Cefoperazone; D000583:Amikacin; D002439:Cefotaxime; D012853:Sisomicin