Vol.58 No.S-1 March 2010
Phase III clinical study of tazobactam/piperacillin (1:8) in pediatric patients with bacterial infection
1)Department of Research Project Studies, Kitasato Institute for Life Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
2)Department of Pediatrics, Meitetsu Hospital
3)Department of Pediatrics, Kawasaki Medical School
4)Department of Pediatrics, Ohta General Hospital, Society of Health Insurance, Fuji Heavy Industries Ltd.
Abstract
The clinical efficacy, safety, and pharmacokinetics of 112.5 mg/kg of tazobactam/piperacillin [TAZ/PIPC (1:8)],β-lactamase inhibitor combined penicillin antibiotic, two or three times a day were evaluated in pediatric patients with bacterial infection.
Clinical efficacy at the end of treatment was 98.2% (54/55) for all infections, 98.0% (49/50) for pneumonia, and 5/5 for pyelonephritis/complicated cystitis. These results were similar to those in adults. Eradication at the end of treatment was 92.9% (65/70) for all causative organisms and 100% (16/16) for β-lactamase-positive organisms.
Adverse events numbering 110 were observed in 75.8% (50/66) and drug-related adverse events numbering 45 in 47.0% (31/66). Main drug-related adverse events were diarrhea in 33.3% (22/66), neutrophil count decreased in 9.5% (2/21), ALT increased in 9.1% (6/66), and AST increased in 9.1% (6/66). No specific adverse events were observed.
Pharmacokinetic parameters of 112.5 mg/kg of TAZ/PIPC in pediatric patients were similar to those of 4.5 g of TAZ/PIPC in healthy adult subjects, so TAZ/PIPC in the treatment of pediatric patients is expected to have similar clinical effects for the same diseases as in adult patients.
Results show that 112.5 mg/kg of TAZ/PIPC (1:8) two or three times a day is very effective in the treatment of pediatric patients with bacterial infection.
Key word
tazobactam/piperacillin, child, PK-PD, clinical trial
Received
June 30, 2009
Accepted
January 12, 2010
Jpn. J. Chemother. 58 (S-1): 88-102, 2010
