Comparison of piperacillin/tazobactam and imipenem/cilastatin, both in combination with tobramycin, administered every 6 h for treatment of nosocomial pneumonia.
This randomized, double-blind, multicenter study compared the efficacy and safety of piperacillin/tazobactam (P/T) and imipenem/cilastatin (IMP), both in combination with an aminoglycoside, in hospitalized patients with acute nosocomial pneumonia (NP). Patients with acute NP, defined as pneumonia with symptoms > or = 48 h after admission or < or =7 days after hospital discharge, received infusions of 4 g/500 mg P/T or 500 mg/500 mg IMP every 6 h. Endpoints were clinical cure and microbiological response rates; pathogen eradication rates; length of hospital stay; hospital readmissions; and adverse events (AEs). Of 437 patients in the intent-to-treat population, 197 were efficacy evaluable. At test-of-cure, response rates were similar between groups. Within the efficacy evaluable population, 68% of P/T patients and 61% of IMP patients were clinically cured (P = 0.256). Microbiological responses for P/T and IMP patients were: eradication, 64% versus 59%; persistence, 29% versus 21%; relapse, 0% versus 5%; and superinfection, 7% versus 15%, respectively. Gram-positive isolates were eradicated in 83% of P/T patients and 75% of IMP patients; Gram-negative pathogens were eradicated in 72% of P/T patients and 77% of IMP patients. Treatment groups had similar number of mean hospital days, readmission rates, and frequency of AEs. This study showed that P/T administered four times per day was as safe and efficacious as IMP in treating hospitalized patients with NP.
University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD 21201, USA. manjari03@aol.com
Manjari
M
Joshi
Michael
M
Metzler
Mary
M
McCarthy
Stephen
S
Olvey
Wedad
W
Kassira
Angel
A
Cooper
D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015377:Cilastatin / Q000008:administration & dosage; D003428:Cross Infection / Q000188:drug therapy; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015378:Imipenem / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010397:Penicillanic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D010878:Piperacillin / Q000008:administration & dosage; D053717:Pneumonia, Ventilator-Associated / Q000188:drug therapy*; D011480:Protease Inhibitors / Q000008:administration & dosage; D000078142:Tazobactam; D014031:Tobramycin / Q000008:administration & dosage; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D004791:Enzyme Inhibitors; D011480:Protease Inhibitors; D015377:Cilastatin; D015378:Imipenem; D010397:Penicillanic Acid; D000078142:Tazobactam; D014031:Tobramycin; D010878:Piperacillin