Vol.60 No.5 September 2012
An open-label multicenter study of tazobactam/piperacillin in the treatment of patients with intra-abdominal infections
1)Department of Infection Control and Prevention, Aichi Medical University, 1-1 Karimata, Yazako, Nagakute, Aichi, Japan
2)Department of Infection Control and Prevention, Hyogo College of Medicine
3)Department of Surgery, Cancer Center Toho University Medical Center Ohashi Hospital
4)Department of Surgery, Gastrointestinal Center, Sano Hospital
5)Department of Surgery, Nagaoka Chuo General Hospital
6)School of Medicine, Keio University
Abstract
An open-label, multicenter study was conducted in 30 sites from February 2010 through March 2011 to evaluate the efficacy and safety of the intravenous administration of tazobactam/piperacillin (TAZ/PIPC) 4.5 g every 8 hours to patients with a clinically or bacteriologically confirmed diagnosis of intra-abdominal infection (peritonitis, intra-abdominal abscess, cholecystitis or cholangitis). The primary efficacy endpoint was the clinical response at the end of treatment. Secondary endpoints included the bacteriological response at both the patient and pathogen levels.
A favorable clinical response rate at the end of treatment was seen in 93.1% (81/87 patients) and in 91.8% (45/49 patients) in evaluable patients with β-lactamase producing pathogens. Favorable clinical response rates in each infection were as follows: peritonitis 90.3% (28/31 patients); peritonitis associated with pelvic inflammatory disease 83.3% (5/6 patients); intra-abdominal abscess 92.9% (26/28 patients); cholecystitis 100% (18/18 patients); and cholangitis 100% (18/18 patients). Based on a baseline pathogen in 70 patients, a favorable bacteriological response rate at the end of treatment was seen in 87.1% (61/70 patients) and in 85.4% (41/48 patients) in evaluable patients with β-lactamase producing pathogens. A favorable pathogen response rate was obtained in 91.3% (146/160 pathogens) and 92.0% (69/75 pathogens) in evaluable patients with β-lactamase producing pathogens.
The incidence of drug-related adverse events (AEs) was 45.0% (45/100 patients). The main AEs reported were diarrhea (15.0%), increased eosinophil count (6.0%), abnormality of liver function, increased blood bilirubin level and abnormality of liver function test (4.0%), and constipation (3.0%). No severe events were observed.
These results suggest that intravenous administration of TAZ/PIPC 4.5 g every 8 hours is effective and safe in the treatment of patients with intra-abdominal infections.
Key word
tazobactam/piperacillin, intra-abdominal infection, peritonitis, clinical trial, extended-spectrum β-lactamase
Received
May 31, 2012
Accepted
June 20, 2012
Jpn. J. Chemother. 60 (5): 560-572, 2012
