Vol.58 No.S-1 March 2010
Phase III tazobactam/piperacillin (1:8) study in patients with sepsis or infective endocarditis
1)Jikei University, 3-25-8 Nishishinbashi, Minato-ku, Tokyo, Japan
2)Department of Urology, Kizawa Memorial Hospital
3)Department of Infectious Disease, Kyorin University School of Medicine
4)Department of Infection Control and Prevention, Aichi Medical University
5)Aki Municipal Hospital
Abstract
Clinical efficacy and safety of tazobactam/piperacillin [TAZ/PIPC (1:8)], β-lactamase inhibitor combined penicillin antibiotic, at a dose of 4.5 g three times a day were evaluated for patients with sepsis and infective endocarditis.
Clinical efficacy at the end of treatment was 95.2% (20/21) for all infection, 95.0% (19/20) for sepsis, and 100% (1/1) for infective endocarditis. Among patients, 7 had positive blood culture and clinical efficacy was 100% (7/7). In 7 patients, 3 had cases caused by β-lactamase positive pathogens.
Drug-related adverse events numbering 48 were observed in 17 patients. Incidence was 73.9% (17/23). Main adverse events were diarrhea at 30.4% (7/23), γ-GTP increase at 30.4% (7/23), AST increase at 21.7% (5/23), eosinophil count increase at 21.7% (5/23), and ALT increase at 17.4% (4/23).
These results indicate that advanced clinical usefulness is expected in sepsis and infective endocarditis treated using TAZ/PIPC (1:8) at a dose of 4.5 g three times a day.
Key word
tazobactam/piperacillin, sepsis, infective endocarditis, clinical trial
Received
July 1, 2009
Accepted
November 2, 2009
Jpn. J. Chemother. 58 (S-1): 73-87, 2010