A randomized prospective study of imipenem-cilastatin with or without amikacin as an empirical antibiotic treatment for febrile neutropenic patients.
To evaluate the effect of adding amikacin (AMK) to imipenem-cilastatin (IPM/CS), we conducted a randomized controlled trial in patients who experienced neutropenia (< 1,000/mm3) and fever (> 38 degrees C) induced by cancer chemotherapy. There were 70 patients who entered the trial; 34 and 36 patients received IPM/CS plus AMK (arm A) and IPM/CS (arm B), respectively. There was no significant difference in patient characteristics between the two groups. Among 67 evaluable patients, 29 of 32 (91%) and 25 of 35 (71%) responded to the antibiotics therapy in arm A and B, respectively, with EORTC criteria (p < .047). Median days of antibiotics administration and of febrile episode over 38 degrees C were not statistically significantly different between arm A and B. There was no patient with severe side effects, such as seizure, and 17 patients (30%) experienced emesis in both groups. These data suggest IPM/CS plus AMK is therapeutically superior to IPM/CS alone in patients with neutropenic fever induced by cancer chemotherapy.
Kojima
A
A
Division of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Shinkai
T
T
Soejima
Y
Y
Okamoto
H
H
Eguchi
K
K
Sasaki
Y
Y
Tamura
T
T
Oshita
F
F
Ohe
Y
Y
Saijo
N
N
D000328:Adult; D000368:Aged; D000583:Amikacin / Q000627:therapeutic use*; D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D015377:Cilastatin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D015378:Imipenem / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000150:complications*; D011446:Prospective Studies; D016896:Treatment Outcome
D015377:Cilastatin; D015378:Imipenem; D000583:Amikacin