title: A multicenter, double-blind, placebo-controlled trial comparing piperacillin-tazobactam with and without amikacin as empiric therapy for febrile neutropenia.
abstract: In a prospective, multicenter, double-blind, randomized clinical trial, we compared the efficacy of piperacillin-tazobactam (4.5 g 3 times daily intravenously) plus placebo versus piperacillin-tazobactam plus amikacin (7.5 mg/kg twice daily intravenously) for the treatment of 760 febrile, adult patients with cancer with chemotherapy-induced profound (<500 neutrophils/mm3) and prolonged (>10 days) neutropenia. A total of 733 patients were assessable for efficacy of the drug regimens, and an overall successful outcome was reported in 49% (179 of 364) of the patients who received monotherapy, compared with 53% (196 of 369) of patients who received combination therapy (P=.2). Response rates were similar with both regimens, as were incidences of bacteremia and clinically documented and possible infections. In our epidemiological setting, the initial empiric combination therapy was not associated with improved outcomes when compared with initial monotherapy.
authors.affiliation: Istituto Medicina Interna e Scienze Oncologiche, Università di Perugia, Perugia, Italy. delfa@unipg.it
authors.forename: A
authors.initials: A
authors.lastname: Del Favero
authors.forename: F
authors.initials: F
authors.lastname: Menichetti
authors.forename: P
authors.initials: P
authors.lastname: Martino
authors.forename: G
authors.initials: G
authors.lastname: Bucaneve
authors.forename: A
authors.initials: A
authors.lastname: Micozzi
authors.forename: G
authors.initials: G
authors.lastname: Gentile
authors.forename: P
authors.initials: P
authors.lastname: Furno
authors.forename: D
authors.initials: D
authors.lastname: Russo
authors.forename: D
authors.initials: D
authors.lastname: D'Antonio
authors.forename: P
authors.initials: P
authors.lastname: Ricci
authors.forename: B
authors.initials: B
authors.lastname: Martino
authors.forename: F
authors.initials: F
authors.lastname: Mandelli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000583:Amikacin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D005334:Fever / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000150:complications*; D010397:Penicillanic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use*; D010878:Piperacillin / Q000627:therapeutic use*; D000077725:Piperacillin, Tazobactam Drug Combination; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000077725:Piperacillin, Tazobactam Drug Combination; D000583:Amikacin; D010397:Penicillanic Acid; D010878:Piperacillin