Dose-finding study of cefozopran for chronic respiratory tract infection

• Published in: CHEMOTHERAPY Vol. 41; no. 8; pp. 863 - 877
• Main Author: Kobayashi, Hiroyuki
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 1993
• Subjects: cefozopran (CZOP); chronic bronchitis; dose finding study
• ISSN: 0009-3165; 1884-5894
• DOI: 10.11250/chemotherapy1953.41.863

A dose-finding study was conducted to determine the optimal effective dosage of a cephem antebiotic, cefozopran (CZOP), administered for chronic respiratory tract infections, using acutely progressing cases as the study subjects, The daily dosage was set at 1 g of the study drug given in 2 divided doses (Group L) and 2 g given in 2 divided doses (Group H). This was contrasted with a daily dosage of 2 g of ceftazidime (CAZ) given in 2 divided doses as a control drug (Group C). The results of the study are summarized below. 1) Clinical efficacy: One case was judged to be “poor” and another case was designated “fair” in Group L and Group H. Group C also showed these results in 2 cases. The efficacy rate was 91.7%(11 cases of 12) for both Groups L and H, and 83.3%(10/12) for Control Group C. 2) Bacteriological effect: All of the 8 causative organisms completely disappeared in Group H, while the eradication rate was 90.9%(10/11) for Group L and 90.0%(9/10) for Group C. 3) Safety: As for side effects, one case in Group L developed rash, and fever was noted in one case in Group H. The appearance rate of abnormal laboratory findings was 23.1%(3/13) for Group L, 21.4%(3/14) for Group H, and 23.1%(3/13) for Group C. However, none of the symptoms or diagnose was serious. 4) Utility: Utility was rated to be 91.7%(11/12) for Group L, 100%(12/12) for Group H, and 83.3%(10/12) for Group C. Based on the above findings, the authors judged that the optimal daily dose is 1-2 g of cefozopran (in 2 divided doses) and thought it appropriate to conduct the Phase III Comparative Study using a daily dose of 2 g (in 2 divided doses) of cefozopran to examine its effectiveness in respiratory tract infections.