A randomized prospective study of imipenem-cilastatin with or without amikacin as an empirical antibiotic treatment for febrile neutropenic patients

Am J Clin Oncol. 1994 Oct;17(5):400-4. doi: 10.1097/00000421-199410000-00009.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Amikacin / therapeutic use*
  • Analysis of Variance
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Cilastatin / therapeutic use*
  • Drug Therapy, Combination / therapeutic use
  • Female
  • Fever / drug therapy*
  • Fever / etiology
  • Humans
  • Imipenem / therapeutic use*
  • Logistic Models
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Neutropenia / complications*
  • Prospective Studies
  • Treatment Outcome

Substances

  • Cilastatin
  • Imipenem
  • Amikacin