Multicenter open-label study of tazobactam/piperacillin in patients with hospital-acquired pneumonia

An open-label, multicenter study was conducted in Japan to evaluate the efficacy and safety of tazobactam (TAZ)/piperacillin(PIPC) (1:8 ratio) in patients with hospital acquired pneumonia. TAZ/PIPC of 4.5 g was administered every 6 hours intravenously, with the following results: 1. Clinical efficacy: Response in evaluable patients at the end of treatment was 88.9% (16/18 patients) and 7 days thereafter was 66.7% (12/18 patients). In 5 patients in whom Pseudomonas aeruginosa was the causative bacteria, 5 responded at the end of treatment and two 7 days after the end of treatment 2. Bacteriological response: Twelve causative bacteria were isolated in 12 patients. Bacteriological response at the end of treatment was 66.7% (8/12 patients) and 33.3% (4/18 patients), 7 days thereafter. 3. Safety: Drug-related adverse events were reported in 19 patients (70.4%) among 27 included in safety analysis. Two or more events reported in the study were diarrhea (7/27 patients, 25.9%); increase in alanine aminotransferase (5/27 patients, 18.5%); increases in aspartate aminotransferase, gamma-glutamyltransferase, and alkaline phosphatase (4/27 patients, 14.8%); pyrexia, increases in eosinophil counts, and proteinuria (each 3/27 patients, 11.1%),and decreases in blood potassium and rash (2/27 patients, 7.4%). Events were mild in 12 (44.4%), moderate in 3 (11.1 %), and severe in 4 (14.8%) of 27 patients. These results suggest that intravenous administration of tazobactam/piperacillin (1:8 ratio) 4.5 g every 6 hours is effective and safe in patients with hospital-acquired pneumonia.