Vol.58 No.S-1 March 2010
Phase III tazobactam/piperacillin (1:8) study in patients with complicated urinary tract infection
1)Surgical Division/Department of Infection Control and Prevention, Kobe University Hospital, 7-5-2 Kusunoki, Chuo-ku, Kobe, Hyogo, Japan
2)Department of Urology, Kizawa Memorial Hospital
3)Department of Urology, Tokyo Metropolitan Fuchu Hospital
4)Division of Microbiology and Infection Control, Kagoshima University Graduate School of Medical and Dental Sciences (Now: Kawahara Urological Clinic)
Abstract
The clinical efficacy and safety of tazobactam/piperacillin [TAZ/PIPC (1:8)], β-lactamase inhibitor combined penicillin antibiotic, at a dose of 4.5 g two or three times a day were evaluated for patients with complicated urinary tract infection.
Overall clinical efficacy was 98.3% (59/60) based on criteria for evaluating clinical efficacy of antimicrobial agents on urinary tract infection (draft, fourth edition). Eradication was 97.7% (85/87). Among those whose infection was caused by β-lactamase-positive pathogens, overall clinical efficacy was 97.9% (46/47) and eradication was 96.2% (51/53). Efficacy was 98.1% (53/54) in patients administered the dose two times a day and 6/6 in those administered the dose three times a day.
Drug-related adverse events numbering 36 were observed in 25 patients, at an incidence of 33.8% (25/74). Main adverse events were diarrhea in 21.6% (16/74), increased γ-GTP in 8.5% (6/71), and increased ALT in 4.1% (3/74).
These results indicate that advanced clinical usefulness can be expected in cases of complicated urinary tract infection in TAZ/PIPC (1:8) treatment at a dose of 4.5 g two or three times a day.
Key word
tazobactam/piperacillin, complicated urinary tract infection, sepsis, clinical trial
Received
June 30, 2009
Accepted
December 8, 2009
Jpn. J. Chemother. 58 (S-1): 62-72, 2010
