Randomized trial comparing netilmicin plus imipenem-cilastatin versus netilmicin plus ceftazidime as empiric therapy for febrile neutropenic bone marrow transplant recipients.
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.
Laszlo
D
D
Bone Marrow Transplant Unit, University of Florence, Careggi Hospital, Florence, Italy.
Bacci
S
S
Bosi
A
A
Fanci
R
R
Guidi
S
S
Saccardi
R
R
Vannucchi
A M
AM
Rossi Ferrini
P
P
D000293:Adolescent; D000328:Adult; D001419:Bacteria / Q000187:drug effects / Q000302:isolation & purification; D001424:Bacterial Infections / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D016026:Bone Marrow Transplantation; D002442:Ceftazidime / Q000627:therapeutic use; D002511:Cephalosporins / Q000627:therapeutic use; D002648:Child; D015377:Cilastatin / Q000627:therapeutic use; D004357:Drug Synergism; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D005334:Fever / Q000150:complications*; D005839:Gentamicins / Q000627:therapeutic use; D006801:Humans; D015378:Imipenem / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009428:Netilmicin / Q000627:therapeutic use; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D011183:Postoperative Complications; D011480:Protease Inhibitors / Q000627:therapeutic use; D013845:Thienamycins / Q000627:therapeutic use; D016896:Treatment Outcome
D002511:Cephalosporins; D005839:Gentamicins; D011480:Protease Inhibitors; D013845:Thienamycins; D015377:Cilastatin; D009428:Netilmicin; D015378:Imipenem; D002442:Ceftazidime