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Abstract

Vol.58 No.S-1 March 2010

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

Naoki Aikawa1), Atsushi Saito2), Kazui Soma3) and Akira Watanabe4)

1)Department of Emergency Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
2)Japanese Red Cross Nagasaki Genbaku Isahaya Hospital
3)Department of Clinical Care and Emergency Medicine, Kitasato University School of Medicine
4)Research Division for Development of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University

Abstract

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.

Key word

tazobactam/piperacillin, hospital-acquired pneumonia, clinical trial

Received

July 17, 2009

Accepted

December 8, 2009

Jpn. J. Chemother. 58 (S-1): 50-61, 2010