Comparative phase III tazobactam/piperacillin and ceftazidime study in the treatment of community-acquired pneumonia

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 272% (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.