Randomized trial comparing netilmicin plus imipenem-cilastatin versus netilmicin plus ceftazidime as empiric therapy for febrile neutropenic bone marrow transplant recipients

J Chemother. 1997 Apr;9(2):95-101. doi: 10.1179/joc.1997.9.2.95.

Abstract

The aim of this study was to compare the clinical and microbiological efficacy of netilmicin plus imipenem-cilastatin (Net + Imi) vs netilmicin plus ceftazidime (Net + Cef) as empiric antimicrobial therapy in bone marrow transplant (BMT) febrile neutropenic patients (pts). Sixty-six pts undergoing BMT for hematological malignancies and solid tumors were randomized to receive Net + Imi or Net + Cef as first-line antibiotic therapy. A lasting return of temperature to normal and complete disappearance of either clinical or cultural signs of infection without any modification of therapy was considered as improvement; the persistence of fever after 72 hours, the addition of a third antibiotic or a protocol change was considered as failure. Sixty-nine episodes were randomized during the course of the trial; bacteriological evidence of infection was obtained in 17 (25%) febrile episodes. Overall outcome based on clinical responses was as follows: 80% of pts on Net + Imi responded compared to 73% of those on Net + Cef. For microbiologically documented infections response rates were 70% in Net + Imi group and 43% in the Net + Cef group (p = ns). Neither septic death nor toxicity were observed. Both empiric regimens were shown to be effective; Net + Imi appeared to be more effective in microbiologically documented infections but there was no statistical significance. In conclusion, both Net + Imi and Net + Cef are active and safe as empirical treatment of febrile episodes in neutropenic BMT pts.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Bacteria / drug effects
  • Bacteria / isolation & purification
  • Bacterial Infections / complications
  • Bacterial Infections / drug therapy*
  • Bacterial Infections / microbiology
  • Bone Marrow Transplantation*
  • Ceftazidime / therapeutic use
  • Cephalosporins / therapeutic use
  • Child
  • Cilastatin / therapeutic use
  • Drug Synergism
  • Drug Therapy, Combination / therapeutic use*
  • Female
  • Fever / complications*
  • Gentamicins / therapeutic use
  • Humans
  • Imipenem / therapeutic use
  • Male
  • Middle Aged
  • Netilmicin / therapeutic use
  • Neutropenia / drug therapy*
  • Neutropenia / etiology
  • Postoperative Complications
  • Protease Inhibitors / therapeutic use
  • Thienamycins / therapeutic use
  • Treatment Outcome

Substances

  • Cephalosporins
  • Gentamicins
  • Protease Inhibitors
  • Thienamycins
  • Cilastatin
  • Netilmicin
  • Imipenem
  • Ceftazidime