Vol.58 No.S-1 March 2010
Comparative phase III tazobactam/piperacillin and ceftazidime study in the treatment of community-acquired pneumonia
1)Research Division for Development of Anti-Infective Agents, Institute of Development, Aging, and Cancer, Tohoku University, 4-1 Seiryo, Aoba-ku, Sendai, Miyagi, Japan
2)Department of Internal Medicine, Shinrakuen Hospital
3)Second Division, Department of Medicine, Hamamatsu University School of Medicine
4)Department of Clinical Infectious Diseases, School of Medicine, Showa University
5)Japanese Red Cross Nagasaki Genbaku Isahaya Hospital
6)Division of Molecular and Clinical Microbiology, Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences (Second Department of Internal Medicine)
7)Second Department of Internal Medicine, Oita University Faculty of Medicine
8)Jikei University School of Medicine
Abstract
A randomized, unblinded, multicenter study was conducted to compare efficacy and safety of tazobactam/piperacillin(TAZ/PIPC), a β-lactamase inhibitor combined with penicillin antibiotic, to those of ceftazidime(CAZ) in patients with community-acquired pneumonia. Subjects were assigned to TAZ/PIPC (4.5 g three times daily) or CAZ (2 g twice daily) groups for a maximum administration of 14 days. Results were obtained as follows:
1. Clinical effect: Response at completion or discontinuation of treatment was 91.3% (95/104 patients) in the TAZ/PIPC group and 89.9% (98/109 patients) in the CAZ group. These results verified the noninferiority of TAZ/PIPC to CAZ in clinical effect. Response evaluated seven days after completion of treatment was 90.8% (89/98 patients) in the TAZ/PIPC group and 84.8% (89/105 patients) in the CAZ group.
2. Bacteriological effect: Bacteria disappearance in patients at completion or discontinuation of treatment was 100% (45/45 patients) in the TAZ/PIPC group and 93.8% (45/48 patients) in the CAZ group. Bacteria disappearance in pathogens was 100% (49/49 strains) in the TAZ/PIPC group and 94.0% (47/50 strains) in the CAZ group. Bacteria disappearance in patients evaluated seven days after completion of treatment was 100% (40/40 cases) in the TAZ/PIPC group and 95.7% (44/46 cases) in the CAZ group. Bacteria disappearance in pathogens was 100% (44/44 strains) in the TAZ/PIPC group and 95.8% (46/48 strains) in the CAZ group.
3. Safety: The incidence of test-drug-related adverse events was 49.3% (67/136 patients) in the TAZ/PIPC group and 37.0% (51/138 patients) in the CAZ group. The incidence of laboratory test abnormalities was 27.2% (37/136 patients) in the TAZ/PIPC group and 31.9% (44/138 patients) in the CAZ group. No statistically significant difference was seen between groups.
These results indicate that a three-times-daily administration of 4.5 g TAZ/PIPC is expected to be highly effective in treating patients with community-acquired pneumonia.
Key word
tazobactam/piperacillin, ceftazidime, community-acquired pneumonia, randomized clinical trial
Received
June 30, 2009
Accepted
November 24, 2009
Jpn. J. Chemother. 58 (S-1): 29-49, 2010
