title: Randomized trial comparing netilmicin plus imipenem-cilastatin versus netilmicin plus ceftazidime as empiric therapy for febrile neutropenic bone marrow transplant recipients.
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.
authors.affiliation: Bone Marrow Transplant Unit, University of Florence, Careggi Hospital, Florence, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Laszlo
authors.forename: S
authors.initials: S
authors.lastname: Bacci
authors.forename: A
authors.initials: A
authors.lastname: Bosi
authors.forename: R
authors.initials: R
authors.lastname: Fanci
authors.forename: S
authors.initials: S
authors.lastname: Guidi
authors.forename: R
authors.initials: R
authors.lastname: Saccardi
authors.forename: A M
authors.initials: AM
authors.lastname: Vannucchi
authors.forename: P
authors.initials: P
authors.lastname: Rossi Ferrini
mesh_terms: 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
chemical_list: D002511:Cephalosporins; D005839:Gentamicins; D011480:Protease Inhibitors; D013845:Thienamycins; D015377:Cilastatin; D009428:Netilmicin; D015378:Imipenem; D002442:Ceftazidime